510(k) K160528 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
ANATOMIC PEEK PTC Cervical Fusion System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Mar 28, 2016 |
| Received | Feb 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160528
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.