510(k) Report

510(k) · Cleared

Cleared

ASTRA-OCT Spine System

K181350510(k) TraditionalCleared Jul 6, 201845-day reviewClass II21 CFR 888.3075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spinecraft, LLC · NKG Posterior Cervical Screw System

Cleared on Jul 6, 2018 as substantially equivalent to K080828 (Depuy Spine, Inc., 2008) and 21 other predicates after a 45-day review. Its family tree reaches back 16 generations to 1985.

Decided
Jul 6, 2018
Review
45 days
Class
Class II
Product code
NKG
Recalls
None
Predicates
22

Its longest line of descent runs back 16 generations to K853033 (1985). 262 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 3 other ancestors2014: 3 other ancestors2013: 2 other ancestors2011: 7 other ancestors2010: 5 other ancestors2009: 18 other ancestors2008: 19 other ancestors2004: 37 other ancestors2007: 12 other ancestors2006: 18 other ancestors2005: 28 other ancestors2003: 15 other ancestors2002: 14 other ancestors2001: 20 other ancestors2000: 11 other ancestors1999: 8 other ancestors1997: 5 other ancestors2012: 1 other ancestor1998: 7 other ancestors1996: 5 other ancestors1995: 4 other ancestors1994: 1 other ancestor1993: 1 other ancestor1984: 1 other ancestor1978: 1 other ancestorReference device: K954696 · Rogozinski Thoracolumbar Spinal Rod · Smith & Nephew Richards, Inc. · 1996Reference device: K143683 · APEX-DL Spine System · Spinecraft, LLC · 2015K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K101070 · Expedium Spine System · Medos International SARL · 2010 · recalled×2: 2 generations cleared close together, K122226 (2012), K123783 (2013) K150552 · ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS · Globus Medical, Inc. · 2015 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 17 other ancestors2 generations back: 32 other ancestors3 generations back: 31 other ancestors4 generations back: 24 other ancestors5 generations back: 33 other ancestors6 generations back: 48 other ancestors7 generations back: 38 other ancestors8 generations back: 14 other ancestors9 generations back: 6 other ancestors10 generations back: 3 other ancestors K150552 · ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS · Globus Medical, Inc. · 2015 · recalledK123783 · Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants · Globus Medical, Inc. · 2013K122226 · Revere Stabilization System · Globus Medical, Inc. · 2012K101070 · Expedium Spine System · Medos International SARL · 2010 · recalledK080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−15−10−50
  1. Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 12 generations between
  3. 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
  4. 2 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
  5. 1 generation backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
  6. This deviceK181350 ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
Show all 16 generations
  1. Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 4 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
  14. 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
  15. 2 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
  16. 1 generation backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
  17. This deviceK181350 ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−15K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−14K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−13K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−12K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−11K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−10K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−9K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−8K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−7K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−6K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−5K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−4K101070Expedium Spine SystemMedos International SARL20101
−3K122226Revere Stabilization SystemGlobus Medical, Inc.2012—
−2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.2013—
−1K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.20151
0 (this device)K181350ASTRA-OCT Spine SystemSpinecraft, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199310
199410
199540
199650
199750
199870
199980
2000110
2001200
2002140
2003150
2004370
2005280
2006180
2007120
2008190
2009180
201050
201170
201210
201320
201430
201530
FIG. 1 — Lineage of K181350, 1985–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NKG device

  1. #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (22)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K080828Mountaineer Oct Spinal System
Summary page 4
…Class II 3. Primary predicate or legally marketed device which is substantially equivalent: x MOUNTAINEER OCT Spinal System (Depuy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434…
Depuy Spine, Inc.2008—
*K110353Mountaineer Oct Spinal System
Summary page 4
…II 3. Primary predicate or legally marketed device which is substantially equivalent: x MOUNTAINEER OCT Spinal System (Depuy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522…
Depuy Spine, Inc.2011—
*K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
Summary page 4
…icate or legally marketed device which is substantially equivalent: x MOUNTAINEER OCT Spinal System (Depuy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 /…
Depuy Synthes, Inc.2015—
*K042508Sumit Oct Spinal System and Mountaineer Oct Spinal System
Summary page 4
…alloy per ASTM F1537 7. Substantial equivalence claimed to predicate devices ASTRA Spine System is substantially equivalent to the MOUNTAINEER OCT Spinal System (K042508 / K080828 / K103100 / K110353 / K132332 / K151885) and VERTEX Reconstruction…
Depuy Spine, Inc.2004—
*K103100Mountaineer Oct Spinal System
Summary page 4
…7. Substantial equivalence claimed to predicate devices ASTRA Spine System is substantially equivalent to the MOUNTAINEER OCT Spinal System (K042508 / K080828 / K103100 / K110353 / K132332 / K151885) and VERTEX Reconstruction…
Depuy Spine, Inc.2010—
*K132332Mountaineer Oct Spinal System
Summary page 4
…ivalence claimed to predicate devices ASTRA Spine System is substantially equivalent to the MOUNTAINEER OCT Spinal System (K042508 / K080828 / K103100 / K110353 / K132332 / K151885) and VERTEX Reconstruction…
Medos International SARL2013—
*K090714Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 4
…NTAINEER OCT Spinal System (Depuy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142…
Medtronic Sofamor Danek2009—
*K091365Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 4
…CT Spinal System (Depuy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synth…
Medtronic Soafamor Danek2009—
*K093434Vertex Reconstruction System and Vertex Select Reconstruction System
Summary page 4
…System (Depuy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine…
Medtronic Sofamor Danek2009—
*K110522Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 4
…puy Spine) cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Sum…
Medtronic Sofamor Danek USA, Inc.2011—
*K123656Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 4
…cleared in 510(k): K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K…
Medtronic Sofamor Danek USA, Inc.2013—
*K143471VERTEX Reconstruction System
Summary page 4
…K080828 / K110353 / K151885 4. Additional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K0…
Medtronic Sofamor Danek USA, Inc.2015—
*K090549Synthes Synapse Transconnector
Summary page 4
…dditional predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine…
Synthes Spine2009—
*K133698Synapse System
Summary page 4
…predicate devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPS…
Synthes USA Products, LLC2014—
*K141897Synapse System, Synthes OC Fusion System
Summary page 4
…devices: x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROT…
Synthes USA Products, LLC2014—
*K142838Synapse Occipital-Cervical-Thoracic (OCT) System
Summary page 4
…x VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROTEX CT Occi…
Synthes USA Products, LLC20151
*K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal System
Summary page 4
…4 / K091365 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K1505…
Depuyacromed2001—
*K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System
Summary page 4
…5 / K093434 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K150552) Globus…
Depuyacromed2002—
*K030103Summit Oct Spinal System Minipolyaxial Screws
Summary page 4
…34 / K110522 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K150552) Globus…
Depuyacromed2003—
*K041203Summit Oct Spinal System
Summary page 4
…22 / K123656 / K143471) Medtronic x SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K150552) Globus Medical…
Depuy Spine, Inc.2004—
*K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
Summary page 4
…38) Synthes Spine x Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine x ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K150552) Globus Medical x Kestrel Posterior Cervical Spine System (K132122) SPINE360 5. Reference predicate devices…
Globus Medical, Inc.20151
*K132122Kestrel Posterior Cervical Spine System
Summary page 4
…5) Depuy Spine x ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K150552) Globus Medical x Kestrel Posterior Cervical Spine System (K132122) SPINE360 5. Reference predicate devices x Rogozinski (K954696) Smith & Nephew Spine x APEX-DL Spine System (K143683…
Omni Surgical, LLC Dba Spine3602014—
†K954696Rogozinski Thoracolumbar Spinal RodSmith & Nephew Richards, Inc.1996—
†K143683APEX-DL Spine SystemSpinecraft, LLC2015—

Also cleared against K080828: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
  • 20 of the 262 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K080828.

How does its category compare?

All NKG devices

NKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · NKG

6in 2025

2015: 172016: 162017: 152018: 122019: 82020: 142021: 72022: 72023: 102024: 32025: 62026 (partial year): 4
2007high 17 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKG

58in 2025

2015: 71 days median2016: 87 days median2017: 108 days median2018: 61 days median2019: 50 days median2020: 59 days median2021: 56 days median2022: 108 days median2023: 58 days median2024: 100 days median2025: 58 days median2026 (partial year): 169 days median
2007high 169 (2026) · low 50 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKG

2in 2020

2018: 12019: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NKG

153in 2025

2015: 42016: 732017: 992018: 1272019: 2142020: 2362021: 7042022: 1752023: 1312024: 2062025: 153
2007high 704 (2021) · low 0 (2007)2025

MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
2015177104
20161687073
201715108099
201812611127
20198501214
202014592236
20217560704
202271080175
202310580131
202431000206
20256580153
202641690—

What is it indicated for?

The ASTRA-OCT Spine System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): • Traumatic spinal fractures and/or Traumatic dislocations; • Instability or deformity; • Failed previous fusions (e.g. pseudoarthrosis); • Tumors involving the cervical/thoracic…

Read the full statement (185 words)

The ASTRA-OCT Spine System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):

• Traumatic spinal fractures and/or Traumatic dislocations;

• Instability or deformity;

• Failed previous fusions (e.g. pseudoarthrosis);

• Tumors involving the cervical/thoracic spine; and

• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm to 6.35mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

Indications for use as stated in the FDA summary.

Also cleared against K080828

7 other devices cite the same predicate.

  • K132332Mountaineer Oct Spinal SystemMedos International SARL · 2013
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
  • K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010
  • K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc. · 2010
  • K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009

More from Spinecraft, LLC

12 FDA decisions under this applicant name. See the company

  • K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC · 2023
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K143683APEX-DL Spine SystemSpinecraft, LLC · 2015

Recent decisions in NKG

The NKG category page

  • K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
  • K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2026
  • K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025

https://510kreport.com/device/K181350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181350: ASTRA-OCT Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181350

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026