510(k) K172269 · PML Bone Cement, Posterior Screw Augmentation
FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Mar 27, 2018 |
| Received | Jul 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172269
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.