510(k) K191148 · PML Bone Cement, Posterior Screw Augmentation
Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 12, 2019 |
| Received | Apr 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191148
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.