510(k) K090850 ยท LYC Bone Grafting Material, Synthetic
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
| Applicant | Apatech , Ltd., Oregon City OR, US |
| Decision | Substantially Equivalent, Jul 30, 2009 |
| Received | Mar 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090850
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2015 | Apatech Limited Actifuse ABX/Actifuse MIS System
A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.