510(k) K201362 · PML Bone Cement, Posterior Screw Augmentation
CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement
| Applicant | Medtronic, Memphis TN, US |
| Decision | Substantially Equivalent, Aug 19, 2020 |
| Received | May 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201362
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.