510(k) Report

510(k) · Cleared

Cleared

SPIRA®-C Integrated Fixation System

K223837510(k) TraditionalCleared Mar 22, 202390-day reviewClass II21 CFR 888.3080

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

Camber Spine Technologies · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Mar 22, 2023 as substantially equivalent to K172446 (Camber Spine Technologies, 2017) and 5 other predicates after a 90-day review. Its family tree reaches back 26 generations to 1984. 4 of the 969 devices in its family, counting itself, have a Class I recall.

Decided
Mar 22, 2023
Review
90 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
6

Its longest line of descent runs back 26 generations to K841189 (1984). 968 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 4 of the 969 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2020: 5 other ancestors2019: 5 other ancestors2017: 19 other ancestors2018: 6 other ancestors2016: 27 other ancestors, 1 with a Class I recall12015: 39 other ancestors, 1 with a Class I recall12014: 40 other ancestors2012: 43 other ancestors2011: 62 other ancestors2009: 58 other ancestors2008: 77 other ancestors, 1 with a Class I recall12007: 34 other ancestors2013: 41 other ancestors2010: 45 other ancestors, 1 with a Class I recall12006: 40 other ancestors2005: 58 other ancestors2004: 69 other ancestors2002: 33 other ancestors2001: 41 other ancestors2003: 41 other ancestors2000: 28 other ancestors1999: 24 other ancestors1996: 18 other ancestors1998: 20 other ancestors1997: 13 other ancestors1993: 4 other ancestors1990: 2 other ancestors1995: 15 other ancestors1992: 6 other ancestors1980: 1 other ancestor1979: 2 other ancestors1978: 1 other ancestor1994: 7 other ancestors1989: 5 other ancestors1987: 3 other ancestors1985: 2 other ancestors1981: 2 other ancestors1988: 2 other ancestors1991: 1 other ancestor1986: 2 other ancestors1984: 1 other ancestorK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015×2: 2 generations cleared close together, K153782 (2016), K161230 (2016) ×3: 3 generations cleared close together, K170962 (2017), K171633 (2017), K172341 (2017) ×3: 3 generations cleared close together, K193593 (2020), K201820 (2020), K203278 (2021) K222270 · HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments · Globus Medical, Inc. · 202219801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 22 other ancestors3 generations back: 68 other ancestors4 generations back: 109 other ancestors, 1 with a Class I recall15 generations back: 160 other ancestors, 1 with a Class I recall16 generations back: 188 other ancestors, 2 with a Class I recall27 generations back: 163 other ancestors8 generations back: 103 other ancestors9 generations back: 61 other ancestors10 generations back: 28 other ancestors11 generations back: 17 other ancestors12 generations back: 12 other ancestors13 generations back: 4 other ancestors14 generations back: 2 other ancestors K222270 · HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments · Globus Medical, Inc. · 2022K203278 · INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers · Globus Medical, Inc. · 2021K201820 · NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K193593 · NuVasive 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K172341 · NuVasive® Modulus TLIF Interbody System · Nu Vasive, Incorporated · 2017K171633 · NuVasive TLX Interbody System · Nu Vasive, Incorporated · 2017K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 2017K161230 · NuVasive Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−25−20−15−10−50
  1. Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 22 generations between
  3. 3 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  4. 2 generations backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
  5. 1 generation backK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  6. This deviceK223837 SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023
Show all 26 generations
  1. Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  22. 5 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
  23. 4 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  24. 3 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  25. 2 generations backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
  26. 1 generation backK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  27. This deviceK223837 SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023

Class I recalls in this family

  • K153660 StealthStation System with Cranial Software4 generations back · 2016
  • K150216 Synergy Cranial5 generations back · 2015
  • K100952 Modification to Synthes Matrix System6 generations back · 2010
  • K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−26K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−25K990148Stackable Cage SystemDepuy Motech Acromed1999—
−24K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−23K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−22K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−21K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−20K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−19K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−18K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−17K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−16K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−15K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−14K121683Acculif TL CageCoalign Innovations, Inc.2012—
−13K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−12K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−11K141217Acculif TL and PL CageStryker Corporation20143
−10K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−9K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−8K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
−6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017—
−5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017—
−4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020—
−3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System…Nu Vasive, Incorporated2020—
−2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers…Globus Medical, Inc.2021—
−1K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—
0 (this device)K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197920
198010
198120
198410
198520
198620
198730
198820
198950
199020
199110
199260
199340
199470
1995150
1996180
1997130
1998200
1999240
2000280
2001410
2002330
2003410
2004690
2005580
2006400
2007340
2008771
2009580
2010451
2011620
2012430
2013410
2014400
2015391
2016271
2017190
201860
201950
202050
FIG. 1 — Lineage of K223837, 1984–2023Source: 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.

4 devices in this family have a Class I recall. 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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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? (6)

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
*K172446SPIRA-C Open Matrix Cervical Interbody
Summary page 5
…ion System is substantially equivalent to the following predicate devices: Primary Predicate(s): Camber Spine Technologies – SPIRA®-C Open Matrix Cervical Interbody (K172446) Additional Predicate(s): Camber Spine Technologies – SPIRA®-C Integrated Fixation System (K193153) Globus Medical – COALITIO…
Camber Spine Technologies2017—
*K193153SPIRA-C Integrated Fixation System
Summary page 5
…amber Spine Technologies – SPIRA®-C Open Matrix Cervical Interbody (K172446) Additional Predicate(s): Camber Spine Technologies – SPIRA®-C Integrated Fixation System (K193153) Globus Medical – COALITION MIS® (K173115) Astura Medical – DOLOMITE Anterior Cervical Stabilization System (K202065) Glubus M…
Camber Spine Technologies2020—
*K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…
Summary page 5
…trix Cervical Interbody (K172446) Additional Predicate(s): Camber Spine Technologies – SPIRA®-C Integrated Fixation System (K193153) Globus Medical – COALITION MIS® (K173115) Astura Medical – DOLOMITE Anterior Cervical Stabilization System (K202065) Glubus Medical – HEDRON Cervical Spacer (K191243, K…
Globus Medical, Inc.2017—
*K202065DOLOMITE Anterior Cervical Stabilization System
Summary page 5
…echnologies – SPIRA®-C Integrated Fixation System (K193153) Globus Medical – COALITION MIS® (K173115) Astura Medical – DOLOMITE Anterior Cervical Stabilization System (K202065) Glubus Medical – HEDRON Cervical Spacer (K191243, K222270) The same SPIRA®-C Integrated Fixation System interbody device, pre…
Astura Medical, LLC2020—
*K191243HEDRON Cervical Spacers
Summary page 5
…K193153) Globus Medical – COALITION MIS® (K173115) Astura Medical – DOLOMITE Anterior Cervical Stabilization System (K202065) Glubus Medical – HEDRON Cervical Spacer (K191243, K222270) The same SPIRA®-C Integrated Fixation System interbody device, previously submitted in K193153 for use with screws,…
Globus Medical, Inc.2019—
*K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…
Summary page 5
…Globus Medical – COALITION MIS® (K173115) Astura Medical – DOLOMITE Anterior Cervical Stabilization System (K202065) Glubus Medical – HEDRON Cervical Spacer (K191243, K222270) The same SPIRA®-C Integrated Fixation System interbody device, previously submitted in K193153 for use with screws, is used i…
Globus Medical, Inc.2022—

Also cleared against K172446: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (4 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
  • K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 39 years and passes through 14 companies; a new generation was cleared every 10 months on median.
  • 117 of the 968 ancestors have a recall of any class; 4 have a Class I recall.
  • 3 other devices also cite its predicate K172446.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

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

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, 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
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

The SPIRA@-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), cervical…

Read the full statement (167 words)

The SPIRA@-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, kyphosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

When used with screws, SPIRA@-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA9-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

Indications for use as stated in the FDA summary.

Also cleared against K172446

3 other devices cite the same predicate.

  • K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
  • K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
  • K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020

More from Camber Spine Technologies

17 FDA decisions under this applicant name. See the company

  • K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies · 2024
  • K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies · 2024
  • K230942SPIRA® Posterior Lumbar SpacersCamber Spine Technologies · 2023
  • K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023
  • K220038Camber Spine Navigation SystemCamber Spine Technologies · 2022

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K223837 · printed Nov 5, 2026

Cite this page

510(k) Report. “K223837: SPIRA®-C Integrated Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223837

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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