Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Sofamor Danck USA, Inc. · 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) |
|---|---|---|---|---|---|
| K150460 | KYPHON (R) HV-R(R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015-04-28 | 64 | 0 |
| K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014-10-27 | 27 | 0 |
| K112444 | ANATOMIC PEEK CERVICAL FUSION SYSTEM | Medtronic Sofamor Danck USA, Inc. | 2011-11-15 | 83 | 0 |
| K110070 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danck USA, Inc. | 2011-06-08 | 149 | 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