510(k) K071206 ยท MQV Filler, Bone Void, Calcium Compound
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
| Applicant | Apatech , Ltd., Oregon City OR, US |
| Decision | Substantially Equivalent, May 31, 2007 |
| Received | May 1, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071206
| 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.