510(k) K143661 ยท GXP Methyl Methacrylate For Cranioplasty
DirectInject
| Applicant | Stryker, Portage MI, US |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Dec 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2021 | Stryker Leibinger GmbH & Co. KG DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected ceme Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.