510(k) Report

510(k) · Cleared

Cleared

ASTRA Spine System

K223273510(k) TraditionalCleared Dec 22, 202259-day reviewClass II21 CFR 888.3070

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

Spinecraft, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 22, 2022 as substantially equivalent to K180179 (Orthofix, Inc., 2018) and 3 other predicates after a 59-day review. Its family tree reaches back 21 generations to 2004. 8 later devices descend from it.

Decided
Dec 22, 2022
Review
59 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
4

Its longest line of descent runs back 21 generations to K040583 (2004). 421 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2015: 4 other ancestors2011: 12 other ancestors2017: 1 other ancestor2016: 4 other ancestors2013: 8 other ancestors2012: 6 other ancestors2010: 18 other ancestors2009: 12 other ancestors2008: 25 other ancestors2007: 14 other ancestors2006: 25 other ancestors2000: 29 other ancestors1996: 12 other ancestors1995: 15 other ancestors2014: 4 other ancestors2005: 25 other ancestors2004: 36 other ancestors2003: 21 other ancestors2002: 25 other ancestors2001: 29 other ancestors1998: 20 other ancestors1997: 13 other ancestors1994: 7 other ancestors1999: 11 other ancestors1978: 1 other ancestor1993: 2 other ancestors1992: 7 other ancestors1990: 3 other ancestors1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors2024: 2 descendants cleared2023: 1 descendant cleared2025: 3 descendants cleared2026: 2 descendants cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017×2: 2 generations cleared close together, K201407 (2020), K202771 (2020) K211323 · ASTRA Spine System · Spinecraft, LLC · 202119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 23 other ancestors3 generations back: 52 other ancestors4 generations back: 63 other ancestors5 generations back: 55 other ancestors6 generations back: 63 other ancestors7 generations back: 63 other ancestors8 generations back: 53 other ancestors9 generations back: 15 other ancestors10 generations back: 9 other ancestors11 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants K211323 · ASTRA Spine System · Spinecraft, LLC · 2021K202771 · CD Horizon Spinal System · Medtronic · 2020K201407 · CD Horizon™ Spinal System · Medtronic Sofamor Danek USA, Inc. · 2020K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−20−15−10−50
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  4. 2 generations backK202771 CD Horizon Spinal SystemMedtronic · 2020
  5. 1 generation backK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
  6. This deviceK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
  7. Descendant · cites it directly · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
  8. Descendant · 2 generations on · 1 of its ownK241464 ARx® SAI Implant SystemLife Spine, Inc. · 2024
  9. Descendant · 2 generations on · 0 of its ownK262067 iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026
  10. Descendant · 2 generations on · 0 of its ownK254274 ARx® SAI Implant SystemLife Spine, Inc. · 2026
  11. Descendant · 2 generations on · 0 of its ownK252322 SIros-X SystemGenesys Spine · 2025
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 7 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 6 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 5 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 4 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 3 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  20. 2 generations backK202771 CD Horizon Spinal SystemMedtronic · 2020
  21. 1 generation backK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
  22. This deviceK223273 ASTRA Spine SystemSpinecraft, LLC · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2023: 12024: 22025: 32026: 2
2023high 3 (2025) · low 1 (2023)2026

Most influential descendants

Showing 5 of 8 · See all
  • K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · cites it directly5descendants
  • K241464ARx® SAI Implant SystemLife Spine, Inc. · 2024 · 2 generations on1descendant
  • K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026 · 2 generations on0descendants
  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 2026 · 2 generations on0descendants
  • K252322SIros-X SystemGenesys Spine · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2020—
−2K202771CD Horizon Spinal SystemMedtronic2020—
−1K211323ASTRA Spine SystemSpinecraft, LLC2021—
0 (this device)K223273ASTRA Spine SystemSpinecraft, LLC2022—
+1K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.2024—
+2K241464ARx® SAI Implant SystemLife Spine, Inc.2024—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.2026—
+2K254274ARx® SAI Implant SystemLife Spine, Inc.2026—
+2K252322SIros-X SystemGenesys Spine2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199030
199270
199320
199470
1995150
1996120
1997130
1998200
1999110
2000290
2001290
2002250
2003210
2004360
2005250
2006250
2007140
2008250
2009120
2010180
2011120
201260
201380
201440
201540
201640
201710
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202420
202530
202620
FIG. 1 — Lineage of K223273, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 NKB? 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 NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (4)

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
*K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…
Summary page 5
…lly marketed device which is substantially equivalent: • Firebird Spinal Fixation Systems, Phoenix MIS Fixation System and JANUS Fenestrated Screws (K180179) / Orthofix Inc. 3. Additional predicate devices: • ASTRA Spine System (K150417 / K211323) / SpineCraft. • REVLOKTM…
Orthofix, Inc.2018—
*K150417Astra Spine System
Summary page 5
…tion Systems, Phoenix MIS Fixation System and JANUS Fenestrated Screws (K180179) / Orthofix Inc. 3. Additional predicate devices: • ASTRA Spine System (K150417 / K211323) / SpineCraft. • REVLOKTM Fenestrated Screw System (K110280) / Globus Medical Inc 4. Description of the device:…
Spinecraft, LLC2015—
*K211323ASTRA Spine System
Summary page 5
…ms, Phoenix MIS Fixation System and JANUS Fenestrated Screws (K180179) / Orthofix Inc. 3. Additional predicate devices: • ASTRA Spine System (K150417 / K211323) / SpineCraft. • REVLOKTM Fenestrated Screw System (K110280) / Globus Medical Inc 4. Description of the device: Th…
Spinecraft, LLC2021—
*K110280Revlok Fenestrated Screw System
Summary page 5
…(K180179) / Orthofix Inc. 3. Additional predicate devices: • ASTRA Spine System (K150417 / K211323) / SpineCraft. • REVLOKTM Fenestrated Screw System (K110280) / Globus Medical Inc 4. Description of the device: The ASTRA Spine System consists of Ø 5.5mm, Ø 6.0mm and Ø 6.2mm long…
Globus Medical, Inc.2011—

Also cleared against K180179: 11 other devices →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245
K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250
K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230

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 18 years and passes through 5 companies; a new generation was cleared every 7 months on median.
  • 50 of the 421 ancestors have a recall of any class.
  • Of its descendants, K233508 (SI-BONE, Inc., 2024) has gone furthest, with 5 descendants of its own.
  • 11 other devices also cite its predicate K180179.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The ASTRA Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The ASTRA Spine System is indicated for non-cervical (T1-S2/1lium) pedicle fixation and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications…

Read the full statement (343 words)

The ASTRA Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The ASTRA Spine System is indicated for non-cervical (T1-S2/1lium) pedicle fixation and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra:; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture and/or dislocation); spinal stenosis; deformities (scoliosis, lordosis and/or kyphosis); spinal tumor; and failed previous fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The ASTRA fenestrated screw when used with other components of the ASTRA Spine System is indicated to provide the surgeon with an open or minimally invasive approach for posterior spinal surgery. The ASTRA fenestrated screw is intended to be used with saline or radiopaque dye.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K180179

11 other devices cite the same predicate.

  • K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
  • K231658VEOS Spinal Fixation SystemSpineway · 2023
  • K222614Zavation Spinal SystemZavation Medical Products, LLC · 2022
  • K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
  • K221776NextGen Pedicle Screw SystemCorelink, LLC · 2022
  • K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems…Orthofix, Inc. · 2021

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
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
  • K143683APEX-DL Spine SystemSpinecraft, LLC · 2015

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K223273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223273: ASTRA 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/K223273

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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