510(k) K152604 ยท PML Bone Cement, Posterior Screw Augmentation
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
| Applicant | Medtronic Sofamor Danek USA, Incorporated, Memphis TN, US |
| Decision | Substantially Equivalent, Jan 6, 2016 |
| Received | Sep 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152604
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.