510(k) Report

FDA applicant

Nu Vasive, Incorporated

San Diego, CA112 decisions2012–20232 recalls

FDA records 112 decisions for Nu Vasive, Incorporated (San Diego, CA) from 2012 to 2023: 112 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 401 predicates, 188 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Nu Vasive, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

4in 2023

2012: 22013: 32014: 122015: 162016: 142017: 222018: 82019: 102020: 102021: 72022: 42023: 4
2012high 22 (2017) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2022

2020: 12022: 1
2012high 1 (2020) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Nu Vasive, Incorporated by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nu Vasive, Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar34decisions
  • NKBThoracolumbosacral Pedicle Screw System10decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar10decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical8decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body7decisions
  • NKGPosterior Cervical Screw System6decisions

Also: MQP (5), PDQ (5), OLO (5), OVE (4), MQV (2), PLR (2).

How long do its 510(k) reviews take?

Since 2016, its 75 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 44 of its 75 were faster than that.

Whose devices does it build on?

Its devices cite 401 predicates; 188 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 375 times; 188 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL…Nu Vasive, Incorporated · 202131cite it
  • K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 201616cite it
  • K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 201713cite it
  • K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 201712cite it
  • K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 201711cite it
  • K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 201710cite it

What has FDA decided for it lately?

  • 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
  • K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
  • K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated · 2022
  • K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022

All 112 as Nu Vasive, Incorporated →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K210574NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US…Jul 19, 2022Class III
  • K143641Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633…Jun 10, 2020Class II