510(k) Report

510(k) · Cleared

Recalled · 2011

Modification to CD Horizon Spinal System

K091974510(k) SpecialCleared Sep 2, 200963-day reviewClass II21 CFR 888.3070Recalls 1

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

Medtronic Sofamor Danek USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 2, 2009 as substantially equivalent to K042025 (Medtronic Sofamor Danek, Inc., 2004) and 15 other predicates after a 63-day review. Its family tree reaches back 8 generations to 2004. 1 of the 714 devices in its family, counting itself, has a Class I recall. 656 later devices descend from it. It has been recalled once.

Decided
Sep 2, 2009
Review
63 days
Class
Class II
Product code
NKB
Recalls
1
Predicates
16

Its longest line of descent runs back 8 generations to K040583 (2004). 57 ancestors in all, the oldest K841189 (1984). 656 later devices descend from it, 18 citing it directly. 1 of the 714 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2006: 4 other ancestors2005: 8 other ancestors2004: 13 other ancestors2003: 5 other ancestors2007: 1 other ancestor2002: 3 other ancestors2000: 4 other ancestors1999: 1 other ancestor1996: 1 other ancestor2001: 5 other ancestors1998: 1 other ancestor1984: 1 other ancestor2022: 48 descendants cleared2011: 4 descendants cleared2014: 33 descendants cleared2013: 24 descendants cleared2015: 36 descendants cleared2010: 2 descendants cleared2012: 14 descendants cleared2016: 37 descendants cleared2018: 48 descendants cleared2025: 57 descendants cleared2020: 46 descendants cleared2023: 67 descendants cleared2017: 44 descendants cleared2024: 60 descendants cleared2021: 44 descendants cleared, 1 with a Class I recall12019: 38 descendants cleared2026: 54 descendants cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) K091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 13 other ancestors2 generations back: 21 other ancestors3 generations back: 12 other ancestors4 generations back: 3 other ancestors 1 generation forward: 18 descendants2 generations forward: 78 descendants3 generations forward: 173 descendants4 generations forward: 167 descendants5 generations forward: 109 descendants, 1 with a Class I recall16 generations forward: 53 descendants7 generations forward: 39 descendants8 generations forward: 18 descendants9 generations forward: 1 descendant K091442 · 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 · 2004−50+5
  1. Root · 8 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 7 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 6 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 5 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 4 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 3 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 2 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 1 generation backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. This deviceK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
  10. Descendant · cites it directly · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. Descendant · cites it directly · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. Descendant · cites it directly · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  13. Descendant · cites it directly · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  14. Descendant · cites it directly · 517 of its ownK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010

Showing 5 of 656 descendants. See all descendants

Descendants cleared per year

2010: 22011: 42012: 142013: 242014: 332015: 362016: 372017: 442018: 482019: 382020: 462021: 442022: 482023: 672024: 602025: 572026: 54
2010high 67 (2023) · low 2 (2010)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 656 · See all
  • K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · cites it directly598descendants
  • K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · cites it directly597descendants
  • K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly597descendants
  • K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly596descendants
  • K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010 · cites it directly517descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−7K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−6K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−5K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−4K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−1K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
0 (this device)K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2009—
+1K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
+1K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
+1K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—
+1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
+1K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199610
199810
199910
200040
200150
200230
200350
2004130
200580
200640
200710
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201140
2012140
2013240
2014330
2015360
2016370
2017440
2018480
2019380
2020460
2021441
2022480
2023670
2024600
2025570
2026540
FIG. 1 — Lineage of K091974, 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.

1 device in this family has 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 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? (16)

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
*K042025Modification to CD Horizon Spinal System
Summary page 2
…HORIZON® Spinal System devices are substantially equivalent to predicate CD HORIZON® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04,…
Medtronic Sofamor Danek, Inc.20044
*K030840Modification to Horizon Spinal System
Summary page 2
…em devices are substantially equivalent to predicate CD HORIZON® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/0…
Medtronic Sofamor Danek, Inc.2003—
*K031655CD Horizon Spinal System
Summary page 2
…ntially equivalent to predicate CD HORIZON® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/0…
Medtronic Sofamor Danek USA, Inc.20031
*K032265CD Horizon Spinal System
Summary page 2
…predicate CD HORIZON® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053…
Medtronic Sofamor Danek2003—
*K033322Modification to CD Horizon Spinal System
Summary page 2
…® Spinal System rods and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05…
Medtronic Sofamor Danek2003—
*K042167Modification to: CD Horizon Spinal System
Summary page 2
…and associated connecting and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06…
Medtronic Sofamor Danek2004—
*K043488Modification to CD Horizon Spinal System
Summary page 2
…and fixation components (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K0822…
Medtronic Sofamor Danek2005—
*K050439CD Horizon Spinal System
Summary page 2
…ponents (K042025 SE 08/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08,…
Medtronic Sofamor Danek, Inc.2005—
*K050809CD Horizon Spinal System
Summary page 2
…8/25/04, K030840 SE 05/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09…
Medtronic Sofamor Danek USA, Inc.2005—
*K053474CD Horizon Spinal System
Summary page 2
…5/15/03, K031655 SE 06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09…
Medtronic Sofamor Danek2006—
*K061579Modification to CD Horizon Spinal System
Summary page 2
…06/27/03, K032265 SE 08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System s…
Medtronic Sofamor Danek2006—
*K061591Modification to CD Horizon Spinal System
Summary page 2
…08/11/03, K033322 SE 12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054…
Medtronic Sofamor Danek, Inc.2006—
*K082236CD Horizon Spinal System
Summary page 2
…12/15/03, K042167 SE 09/08/04, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054 SE 08/19/05). === P…
Medtronic Sofamor Danek2008—
*K090390CD Horizon Spinal System
Summary page 2
…4, K043488 SE 03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054 SE 08/19/05). 4…
Medtronic Sofamor Danek2009—
*K091442CD Horizon Spinal System
Cleared while this submission was under review
Summary page 2
…03/22/05, K050439 SE 03/24/05, K050809 SE 06/14/05, K053474 SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054 SE 08/19/05). 4 DEPARTMENT OF HE…
Medtronic Sofamor Danek2009—
*K052054TSRH Spinal System
Summary page 2
…SE01/09/05, K061579 SE 08/11/06, K061591 SE 09/08/06, K082236 SE 10/10/08, K090390 SE 05/15/09, K091442 SE 07/15/09) and TSRH® Spinal System screws (K052054 SE 08/19/05). 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Medtronic Sofamor Danek…
Medtronic Sofamor Danek2005—

Also cleared against K042025: 36 other devices →

What descends from it? (656)

See all 656

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

NumberDeviceApplicantDecidedDescendants
K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598
K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597
K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597
K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2011596
K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517
K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357
K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316
K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273
K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207
K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 28, 2011Not classifiedZ-2876-2011OtherScrews are longer then size etched on the screw.

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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4 months on median.
  • 8 of the 57 ancestors have a recall of any class.
  • Of its descendants, K102555 (Medtronic Sofamor Danek USA, Inc., 2010) has gone furthest, with 598 descendants of its own.
  • 36 other devices also cite its predicate K042025.

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. 2009, 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 CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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)…

Read the full statement (238 words)

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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; pseudarthritis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACYTM 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

The CD HORIZON SPIRETM Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S 1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.

In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications'of use.

Indications for use as stated in the FDA summary.

Also cleared against K042025

36 other devices cite the same predicate.

  • K223494CD Horizon Spinal SystemMedtronic · 2023
  • K221244CD Horizon™ Spinal SystemMedtronic · 2022
  • K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
  • K210637CD Horizon™ Spinal SystemMedtronic · 2021
  • K202771CD Horizon Spinal SystemMedtronic · 2020
  • K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic · 2020

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

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/K091974 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091974: Modification to CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091974

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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