Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synovis Surgical Innovations · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
219 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | 2013-03-08 | 219 | 0 |
| K083039 | VERITAS COLLAGEN MATRIX (DRY) | Synovis Surgical Innovations | 2008-11-26 | 43 | 0 |
| K062915 | VERITAS COLLAGEN MATRIX | Synovis Surgical Innovations | 2006-12-06 | 70 | 0 |
| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | Synovis Surgical Innovations | 2004-10-27 | 128 | 8 |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CON | Synovis Surgical Innovations | 2004-04-14 | 56 | 1 |
| K040119 | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, | Synovis Surgical Innovations | 2004-03-17 | 57 | 0 |
| K040001 | STEERABLE STYLET | Synovis Surgical Innovations | 2004-03-09 | 67 | 0 |
| K030879 | VERITAS COLLAGEN MATRIX | Synovis Surgical Innovations | 2003-04-24 | 35 | 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