Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Sofamor Danek USA, Incorporated · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated | Medtronic Sofamor Danek USA, Incorporated | 2016-01-06 | 117 | 0 |
| K150200 | CD HORIZON Growth Rod Conversion Set | Medtronic Sofamor Danek USA, Incorporated | 2015-02-25 | 27 | 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