510(k) K091321 ยท MQV Filler, Bone Void, Calcium Compound
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
| Applicant | Bacterin International, Inc., Belgrade MT, US |
| Decision | Substantially Equivalent, Sep 11, 2009 |
| Received | May 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2013 | Bacterin International, Inc. OsteoSelect DBM Putty
Product Usage:
Orthopedic bone filler Terminated |
MBP | None listed |
| Feb 11, 2013 | Bacterin International, Inc. Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B0900 Terminated |
MBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.