Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ossacur AG — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051047 | COLLOSS E BONE VOID FILLER | Ossacur AG | 2006-03-08 | 317 | 0 |
| K053374 | OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM | Ossacur AG | 2006-02-21 | 78 | 0 |
| K050416 | OSSAPLAST ORTHO | Ossacur AG | 2005-03-29 | 39 | 0 |
| K042305 | OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0 | Ossacur AG | 2004-10-21 | 57 | 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