510(k) Report

510(k) · Cleared

Cleared

NuVasive TLX Interbody System

K171633510(k) TraditionalCleared Sep 28, 2017118-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

Nu Vasive, Incorporated · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Sep 28, 2017 as substantially equivalent to K170962 (Nu Vasive, Incorporated, 2017) and 5 other predicates after a 118-day review. Its family tree reaches back 20 generations to 1984. 251 later devices descend from it.

Decided
Sep 28, 2017
Review
118 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 20 generations to K841189 (1984). 204 ancestors in all. 251 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 3 other ancestors2015: 4 other ancestors2014: 8 other ancestors2007: 12 other ancestors2013: 9 other ancestors2012: 7 other ancestors2011: 12 other ancestors2009: 15 other ancestors2008: 29 other ancestors2010: 12 other ancestors2006: 7 other ancestors2005: 10 other ancestors2003: 13 other ancestors2002: 9 other ancestors1999: 2 other ancestors2004: 18 other ancestors2001: 10 other ancestors1996: 2 other ancestors2000: 2 other ancestors2020: 14 descendants cleared2018: 6 descendants cleared2017: 1 descendant cleared2022: 28 descendants cleared2021: 20 descendants cleared2024: 53 descendants cleared2026: 42 descendants cleared2025: 45 descendants cleared2019: 6 descendants cleared2023: 36 descendants clearedK841189 · 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) K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 16 other ancestors3 generations back: 41 other ancestors4 generations back: 48 other ancestors5 generations back: 36 other ancestors6 generations back: 26 other ancestors7 generations back: 12 other ancestors8 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 27 descendants3 generations forward: 53 descendants4 generations forward: 73 descendants5 generations forward: 57 descendants6 generations forward: 22 descendants7 generations forward: 8 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K170962 · 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. · 1984−20−15−10−50+5
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 16 generations between
  3. 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  4. 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  5. 1 generation backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  6. This deviceK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  7. Descendant · cites it directly · 163 of its ownK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
  8. Descendant · 2 generations on · 157 of its ownK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  9. Descendant · 2 generations on · 156 of its ownK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  10. Descendant · cites it directly · 115 of its ownK173892 NuVasive® XLX Interbody SystemNu Vasive, Incorporated · 2018
  11. Descendant · cites it directly · 113 of its ownK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
Show all 20 generations
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 1 generation backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. This deviceK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017

Showing 5 of 251 descendants. See all descendants

Descendants cleared per year

2017: 12018: 62019: 62020: 142021: 202022: 282023: 362024: 532025: 452026: 42
2017high 53 (2024) · low 1 (2017)2026

Most influential descendants

Showing 5 of 251 · See all
  • K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly163descendants
  • K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020 · 2 generations on157descendants
  • K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2020 · 2 generations on156descendants
  • K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated · 2018 · cites it directly115descendants
  • K180480ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly113descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−19K990148Stackable Cage SystemDepuy Motech Acromed1999—
−18K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−17K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−16K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−15K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−14K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−13K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−12K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−11K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−10K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−9K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−8K121683Acculif TL CageCoalign Innovations, Inc.2012—
−7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−6K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−5K141217Acculif TL and PL CageStryker Corporation20143
−4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−1K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
0 (this device)K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017—
+1K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System…Nu Vasive, Incorporated2020—
+1K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018—
+1K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200020
2001100
200290
2003130
2004180
2005100
200670
2007120
2008290
2009150
2010120
2011120
201270
201390
201480
201540
201630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201860
201960
2020140
2021200
2022280
2023360
2024530
2025450
2026420
FIG. 1 — Lineage of K171633, 1984–2026Source: 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 MAX? 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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
*K170962NuVasive® CoRoent® Thoracolumbar System
Cleared while this submission was under review
Summary page 4
…PHM C. Predicate Devices The subject TLX Interbody System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Thoracolumbar System (K170962) serves as the primary predicate device, while NuVasive TLX Interbody System (K153627), NuVasive CoRoent® System (K1416…
Nu Vasive, Incorporated2017—
*K153627NuVasive® TLX Interbody System
Summary page 4
…ent to multiple predicate devices. NuVasive CoRoent Thoracolumbar System (K170962) serves as the primary predicate device, while NuVasive TLX Interbody System (K153627), NuVasive CoRoent® System (K141665), NuVasive CoRoent System (K071795), NuVasive Lumbar Interbody Implants (K161230),…
Nu Vasive, Incorporated2016—
*K141665NuVasive CoRoent System
Summary page 4
…uVasive CoRoent Thoracolumbar System (K170962) serves as the primary predicate device, while NuVasive TLX Interbody System (K153627), NuVasive CoRoent® System (K141665), NuVasive CoRoent System (K071795), NuVasive Lumbar Interbody Implants (K161230), and NuVasive MLX – Medial Lateral Expanda…
Nuvasive, Inc.2015—
*K071795Nuvasive Coroent System
Summary page 4
…m (K170962) serves as the primary predicate device, while NuVasive TLX Interbody System (K153627), NuVasive CoRoent® System (K141665), NuVasive CoRoent System (K071795), NuVasive Lumbar Interbody Implants (K161230), and NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System (K…
Nuvasive, Inc.2007—
*K161230NuVasive Lumbar Interbody Implants
Summary page 4
…vice, while NuVasive TLX Interbody System (K153627), NuVasive CoRoent® System (K141665), NuVasive CoRoent System (K071795), NuVasive Lumbar Interbody Implants (K161230), and NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System (K140770) are additional predicate devices. D. Dev…
Nu Vasive, Incorporated2016—
*K140770MLX - Medial Lateral Expandable Lumbar Interbody System
Summary page 4
…141665), NuVasive CoRoent System (K071795), NuVasive Lumbar Interbody Implants (K161230), and NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System (K140770) are additional predicate devices. D. Device Description The TLX Interbody intervertebral fusion device is designed to ad…
Nu Vasive, Incorporated2014—

Also cleared against K170962: 11 other devices →

What descends from it? (251)

See all 251

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

NumberDeviceApplicantDecidedDescendants
K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163
K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115
K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113
K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.201855
K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223
K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203
K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211
K261049Scala® TLSpineart SA20260
K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240

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 12 companies; a new generation was cleared every 10 months on median.
  • 21 of the 204 ancestors have a recall of any class.
  • Of its descendants, K172341 (Nu Vasive, Incorporated, 2017) has gone furthest, with 163 descendants of its own.
  • 11 other devices also cite its predicate K170962.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

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

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The NuVasive TLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of…

Read the full statement (182 words)

The NuVasive TLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The TLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Indications for use as stated in the FDA summary.

Also cleared against K170962

11 other devices cite the same predicate.

  • K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System…Nu Vasive, Incorporated · 2021
  • K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
  • K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System…Nu Vasive, Incorporated · 2020
  • K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
  • K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
  • K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018

More from Nu Vasive, Incorporated

112 FDA decisions under this applicant name. See the company

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
  • K230989Rod Registration FrameNu Vasive, Incorporated · 2023
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023
  • K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated · 2022

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K171633 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171633: NuVasive TLX Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171633

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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