Nuvasive, Inc.: FDA clearances and approvals
Nuvasive, Inc. has 92 FDA 510(k) clearances (first 1999, latest 2024), plus 1 PMA decision, across 28 product codes in 5 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 69 days, against 92 days for all cleared 510(k)s in the same product codes. openFDA lists 36 product recalls by a recalling firm named Nuvasive, Inc. It is the industry lead sponsor of 16 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 9 | 93 |
| 2013 | 9 | 153 |
| 2014 | 4 | 138 |
| 2015 | 2 | 228 |
| 2016 | 0 | — |
| 2017 | 1 | 69 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 74 |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 2 | 142 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Nuvasive, Inc.'s cleared 510(k)s took a median 69 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 21 | 21 |
| NKB | Thoracolumbosacral Pedicle Screw System | 9 | 9 |
| ETN | Stimulator, Nerve | 6 | 6 |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 6 |
| GWF | Stimulator, Electrical, Evoked Response | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 4 | 4 |
| MRW | System, Facet Screw Spinal Device | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
Plus 18 more product codes.
Review panels
- Orthopedic (73)
- Neurology (8)
- Ear, Nose and Throat (6)
- General and Plastic Surgery (4)
- Anesthesiology (2)
Most recent Nuvasive, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233706 | Bendini Cloud Application | OLO | 2024-08-02 | 256 |
| K240507 | NuVasive AttraX Scaffold | MQV | 2024-03-20 | 28 |
| K223731 | NuVasive Modulus-C Interbody System | ODP | 2023-01-12 | 30 |
| K211757 | Simplify Disc | QLQ | 2021-08-20 | 74 |
| K173117 | NuVasive® VersaTie System | OWI | 2017-12-07 | 69 |
| K141665 | NuVasive CoRoent System | MAX | 2015-03-13 | 263 |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | MQP | 2015-02-20 | 193 |
| K141968 | NUVASIVE NVM5 SYSTEM | PDQ | 2014-11-14 | 116 |
| K140319 | COROENT TI-C SYSTEM | MAX | 2014-10-09 | 241 |
| K140162 | AP EXPANDABLE XLIF SYSTEM | MAX | 2014-07-02 | 161 |
82 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100012 | PMA | NUVASIVE PCM CERVICAL DISC SYSTEM | 2012-10-26 |
Recalls
36 product recalls in 6 recall events; 3 initiated in the last five years. Most recent: 2022-11-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Nuvasive, Inc. is the industry lead sponsor of 16 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT06714110: A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children. (Enrolling by invitation, started 2025-03-13)
- NCT06741514: A Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures (Enrolling by invitation, started 2024-03-25)
- NCT05691231: Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels (Enrolling by invitation, started 2023-01-18)
- NCT05566704: Retrospective Modulus ALIF Study (Completed, started 2022-08-18)
- NCT04770571: Posterior Cervical Fixation Study (Enrolling by invitation, started 2022-05-10)
Frequently asked questions
How many FDA 510(k) clearances does Nuvasive, Inc. have?
Nuvasive, Inc. has 92 FDA 510(k) clearances (first 1999, latest 2024), plus 1 PMA decision, across 28 product codes in 5 review panels.
How long does FDA take to clear Nuvasive, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nuvasive, Inc.'s cleared 510(k)s is 90 days. Since 2017: 69 days, versus 92 days for all cleared 510(k)s in the same product codes.
What devices does Nuvasive, Inc. make?
Its most frequent FDA product codes are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 21); NKB (Thoracolumbosacral Pedicle Screw System, 9); ETN (Stimulator, Nerve, 6).
Has Nuvasive, Inc. had device recalls?
openFDA lists 36 product recalls in 6 recall events by a recalling firm whose name matches Nuvasive, Inc; the most recent began 2022-11-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 92 Nuvasive, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Nuvasive, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.