Nuvasive Specialized Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Nuvasive Specialized Orthopedics, Inc.” (first 2016, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 126 days, against 119 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 |
|---|---|---|
| 2016 | 2 | 163 |
| 2017 | 6 | 56 |
| 2018 | 1 | 36 |
| 2019 | 3 | 132 |
| 2020 | 6 | 130 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 287 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nuvasive Specialized Orthopedics, Inc. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 17 | 17 |
| PGN | Growing Rod System- Magnetic Actuation | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (21)
Most recent Nuvasive Specialized Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261651 | Precice Max System and Precice Ankle Salvage System | HSB | 2026-06-18 | 30 |
| K230765 | Precice Ankle Salvage System | HSB | 2023-08-29 | 162 |
| K220234 | Precice Intramedullary Limb Lengthening System | HSB | 2023-03-15 | 412 |
| K202348 | External Remote Controller ERC 4P | HSB | 2020-12-22 | 126 |
| K200430 | Precice® Ankle Salvage System | HSB | 2020-09-16 | 208 |
| K201567 | Precice® Bone Transport System | HSB | 2020-08-10 | 60 |
| K201543 | MAGEC® System | PGN | 2020-07-30 | 51 |
| K193617 | Precice® Screws | HSB | 2020-05-08 | 134 |
| K193016 | PRECICE Bone Transport System | HSB | 2020-05-08 | 192 |
| K192181 | PRECICE Plating System | KTT | 2019-11-07 | 87 |
11 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 7 recall events; 3 initiated in the last five years. Most recent: 2024-09-30.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nuvasive, Inc. (92 510(k)s)
- Nuvasive Specialized Orthopedics, Incorporated (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nuvasive Specialized Orthopedics, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Nuvasive Specialized Orthopedics, Inc.” (first 2016, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nuvasive Specialized Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuvasive Specialized Orthopedics, Inc. is 126 days. Since 2017: 126 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nuvasive Specialized Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 17); PGN (Growing Rod System- Magnetic Actuation, 3); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1).
Next steps
- See all 21 Nuvasive Specialized Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Nuvasive Specialized Orthopedics, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.