Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Linvatec Corporation D/B/A Conmed Linvatec · 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) |
|---|---|---|---|---|---|
| K131035 | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SU | Linvatec Corporation D/B/A Conmed Linvatec | 2013-07-02 | 81 | 0 |
| K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | Linvatec Corporation D/B/A Conmed Linvatec | 2013-03-29 | 31 | 0 |
| K121890 | GENESYS PRESSFT SUTURE ANCHOR | Linvatec Corporation D/B/A Conmed Linvatec | 2012-08-22 | 55 | 0 |
| K112965 | NANO SUTURE ANCHOR | Linvatec Corporation D/B/A Conmed Linvatec | 2011-11-02 | 28 | 6 |
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