510(k) K081071 ยท HWC Screw, Fixation, Bone
SYNTHES 6.5MM MIDFOOT FUSION BOLT
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, May 1, 2008 |
| Received | Apr 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2013 | Synthes USA HQ, Inc. Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.