Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baumer, S.A — 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) |
|---|---|---|---|---|---|
| K011504 | BAUMER LOCKING NAIL | Baumer, S.A | 2001-08-14 | 90 | 0 |
| K003975 | BAUMER CEMENTED HIP PROSTHESIS | Baumer, S.A | 2001-03-19 | 87 | 0 |
| K003976 | BAUMER MULLER HIP PROSTHESIS | Baumer, S.A | 2001-03-19 | 87 | 0 |
| K001571 | BAUMER FEMORAL HEAD | Baumer, S.A | 2000-08-04 | 74 | 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