Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zimvie Spine (Zimmer Biomet Spine, Inc.) · 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) |
|---|---|---|---|---|---|
| K240647 | Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-04-05 | 29 | 0 |
| K240539 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-03-15 | 18 | 0 |
| K233443 | Vital™ Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-11-16 | 28 | 0 |
| K230116 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-10-11 | 267 | 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