510(k) K192818 ยท PML Bone Cement, Posterior Screw Augmentation
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
| Applicant | Stryker Corporation, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Mar 31, 2020 |
| Received | Oct 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192818
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.