510(k) K130498 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
| Applicant | Bacterin International, Inc., Belgrade MT, US |
| Decision | Substantially Equivalent, May 31, 2013 |
| Received | Feb 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2019 | XTANT MEDICAL INC OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect Terminated |
MBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.