Nu Vasive, Incorporated: FDA filings under this applicant name
FDA lists 112 510(k) clearances under the applicant name “Nu Vasive, Incorporated” (first 2012, latest 2023), across 22 product codes in 5 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 91 days, against 100 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Globus Medical, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 82 |
| 2013 | 3 | 126 |
| 2014 | 12 | 114 |
| 2015 | 16 | 99 |
| 2016 | 14 | 95 |
| 2017 | 22 | 92 |
| 2018 | 8 | 134 |
| 2019 | 10 | 63 |
| 2020 | 10 | 90 |
| 2021 | 7 | 90 |
| 2022 | 4 | 121 |
| 2023 | 4 | 53 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nu Vasive, Incorporated took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 34 | 34 |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 | 10 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 10 | 10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 8 | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 7 |
| NKG | Posterior Cervical Screw System | 6 | 6 |
| MQP | Spinal Vertebral Body Replacement Device | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 5 | 5 |
| PDQ | Neurosurgical Nerve Locator | 5 | 5 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 4 |
Plus 12 more product codes.
Review panels
- Orthopedic (101)
- Neurology (5)
- Radiology (4)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Nu Vasive, Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | ODP | 2023-07-11 | 27 |
| K230894 | NuVasive Modulus ALIF System | OVD | 2023-06-16 | 77 |
| K230989 | Rod Registration Frame | OLO | 2023-05-05 | 29 |
| K223181 | NuVasive Reline System | NKB | 2023-01-11 | 92 |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | OVD | 2022-10-21 | 127 |
| K221388 | NuVasive Reline Cervical System | NKG | 2022-09-09 | 119 |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | MAX | 2022-06-21 | 123 |
| K213654 | NuVasive Reline Cervical System | NKG | 2022-02-23 | 96 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | MAX | 2021-12-23 | 367 |
| K212446 | NuVasive Anterior Cervical Plate Systems | KWQ | 2021-11-03 | 90 |
102 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nu Vasive, Incorporated.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nu Vasive, Incorporated?
FDA lists 112 510(k) clearances under the applicant name “Nu Vasive, Incorporated” (first 2012, latest 2023), across 22 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nu Vasive, Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nu Vasive, Incorporated is 98 days. Since 2017: 91 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nu Vasive, Incorporated?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 34); NKB (Thoracolumbosacral Pedicle Screw System, 10); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 10).
Next steps
- See all 112 Nu Vasive, Incorporated clearances with predicates and recalls
- Run predicate analysis for product code MAX, Nu Vasive, Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.