Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HTH · 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) |
|---|---|---|---|---|---|
| K861576 | SHORTENING OSTEOTOMY GUIDE | Osteotomy Guide Co. | 1986-05-12 | 14 | 0 |
| K841470 | REESE OSTEOTOMY GUIDE SYS | Osteotomy Guide Co. | 1984-05-23 | 44 | 0 |
| K822305 | ORTHO-LEVEL | Frontier Products | 1982-08-20 | 24 | 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