510(k) K121575 ยท HSB Rod, Fixation, Intramedullary And Accessories
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
| Applicant | Ortho Solutions Limited, Prior Lake MN, US |
| Decision | Substantially Equivalent, Sep 14, 2012 |
| Received | May 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2017 | Ortho Solutions Inc Oxford/Oxbridge AFN End Cap
10 mm x 5 mm tp 12 mm x10 mm
The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.