510(k) K150582 · NDN Cement, Bone, Vertebroplasty
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
| Applicant | Stryker Corporation, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Jun 12, 2015 |
| Received | Mar 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2016 | Stryker Instruments Div. of Stryker Corporation Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement.
Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, Terminated |
NDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.