Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Linvatec Biomaterials, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052080 | MATRYX INTERFERENCE SCREW | Linvatec Biomaterials, Inc. | 2005-08-25 | 23 | 0 |
| K041288 | MODIFICATION TO SMARTPIN | Linvatec Biomaterials, Inc. | 2004-06-10 | 28 | 0 |
| K032894 | OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 23 | Linvatec Biomaterials, Inc. | 2004-05-07 | 233 | 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