Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NDF · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051642 | FR.O.H. CALCANEUS REPAIR SYSTEM | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-08-22 | 63 | 1 |
| K021749 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | Ebi, L.P. | 2002-08-12 | 76 | 0 |
| K010551 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | Ebi, L.P. | 2001-05-17 | 80 | 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