Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integra Life Sciences — 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) |
|---|---|---|---|---|---|
| K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX | Integra Life Sciences | 2012-06-15 | 108 | 0 |
| K103248 | INTEGRITY SPINAL CARE SYSTEM | Integra Life Sciences | 2011-04-05 | 153 | 0 |
| K103742 | ACCELL EVO3 (FORMERLY ACCELL A2I) | Integra Life Sciences | 2011-03-17 | 84 | 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