510(k) K091193 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
ACCELL EVO3C
| Applicant | Isotis Orthobiologics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 10, 2009 |
| Received | Apr 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091193
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2014 | Integra LifeSciences Corp. Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160.
Product Usage:
Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and ga Terminated |
MBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.