510(k) K102392 ยท MQV Filler, Bone Void, Calcium Compound
MICROFUSE PUTTY AND MICROFUSE ST MIS
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Dec 22, 2010 |
| Received | Aug 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2013 | Globus Medical, Inc. Globus Medical MicroFuse Putty, 2.5cc and 10cc.
Product Usage:
MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Micro Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.