Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuvasive Specialized Orthopedics, Incorporated · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | 2024-02-06 | 90 | 0 |
| K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | 2023-12-15 | 137 | 1 |
| K171791 | MAGEC® System | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-31 | 76 | 1 |
| K170939 | Supplemental Instrument Trays | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-08 | 131 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda