Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Etex Corporation — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
525 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone | Etex Corporation | 2024-12-18 | 26 | 0 |
| K182107 | CarriGen PF | Etex Corporation | 2018-08-31 | 28 | 0 |
| K132868 | CARRICELL | Etex Corporation | 2015-02-20 | 525 | 0 |
| K141245 | ETEX MIXING AND DELIVERY SYSTEM | Etex Corporation | 2014-07-09 | 56 | 0 |
| K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE | Etex Corporation | 2010-12-03 | 66 | 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