Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apatech , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
202 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE | Apatech , Ltd. | 2009-07-30 | 122 | 0 |
| K082575 | ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BON | Apatech , Ltd. | 2008-11-25 | 81 | 0 |
| K081979 | ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GR | Apatech , Ltd. | 2008-11-06 | 118 | 0 |
| K082073 | ACTIFUSE FLOW BONE GRAFT SUBSTITUTE | Apatech , Ltd. | 2008-09-11 | 50 | 0 |
| K080736 | ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE | Apatech , Ltd. | 2008-04-16 | 30 | 0 |
| K071206 | ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE | Apatech , Ltd. | 2007-05-31 | 30 | 0 |
| K040082 | PORE-SI BONE GRAFT SUBSTITUTE | Apatech , Ltd. | 2004-08-04 | 202 | 0 |
| K033722 | APAPORE BONE GRAFT SUBSTITUTE | Apatech , Ltd. | 2004-05-07 | 163 | 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