510(k) K060763 ยท GXP Methyl Methacrylate For Cranioplasty
STRYKER INJECTABLE CEMENT
| Applicant | Stryker, Portage MI, US |
| Decision | Substantially Equivalent, Sep 22, 2006 |
| Received | Mar 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2013 | Stryker Craniomaxillofacial Division Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.