510(k) K113079 ยท MTJ Wax, Bone
SYNTHES HEMOSTATIC BONE PUTTY
| Applicant | Synthes (Usa) Products, LLC/Norian Corporation, West Chester PA, US |
| Decision | Substantially Equivalent, Dec 13, 2011 |
| Received | Oct 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2015 | Synthes, Inc. Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. Terminated |
MTJ | None listed |
| Aug 16, 2012 | Synthes USA HQ, Inc. Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S.
Indicated for use as a water soluble implant material and for use in the co Terminated |
MTJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.