Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Depuy Spine, A Johnson & Johnson Company · 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) |
|---|---|---|---|---|---|
| K131802 | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM | Depuy Spine, A Johnson & Johnson Company | 2013-09-12 | 85 | 0 |
| K102249 | EXPEDIUM SPINE SYSTEM | Depuy Spine, A Johnson & Johnson Company | 2010-12-16 | 129 | 0 |
| K071927 | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | Depuy Spine, A Johnson & Johnson Company | 2007-11-21 | 132 | 0 |
| K071495 | EXPEDIUM 4.5MM SPINE SYSTEM | Depuy Spine, A Johnson & Johnson Company | 2007-06-29 | 29 | 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