510(k) K083612 ยท HWC Screw, Fixation, Bone
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
| Applicant | Cayenne Medical, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Mar 4, 2009 |
| Received | Dec 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2013 | Cayenne Medical Inc. AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.