Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sanacor — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090477 | ALPINE PEDICLE SCREW SYSTEM | Sanacor | 2009-07-27 | 153 | 0 |
| K073500 | ACTIVE ANTERIOR CERVICAL PLATE SYSTEM | Sanacor | 2008-07-03 | 203 | 0 |
| K070933 | LOWTOP PEDICLE SCREW SYSTEM | Sanacor | 2007-06-13 | 71 | 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