Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Linvatec Biomaterials, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042966 | DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE | Linvatec Biomaterials, Ltd. | 2004-11-19 | 22 | 0 |
| K042517 | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS | Linvatec Biomaterials, Ltd. | 2004-10-08 | 23 | 0 |
| K042295 | SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018 | Linvatec Biomaterials, Ltd. | 2004-09-16 | 23 | 0 |
| K032447 | CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN F | Linvatec Biomaterials, Ltd. | 2004-04-16 | 252 | 0 |
| K031981 | 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 | Linvatec Biomaterials, Ltd. | 2003-07-25 | 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