510(k) K103822 ยท MTJ Wax, Bone
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
| Applicant | Synthes USA Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, May 19, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.