510(k) K132496 ยท LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
ARTHROSURFACE TOEMOTION
| Applicant | Arthrosurface, Inc., Franklin MA, US |
| Decision | Substantially Equivalent, Feb 26, 2014 |
| Received | Aug 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2015 | Arthrosurface, Inc. Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002
The component in question is the hex driver (part number 2009-4001). Terminated |
LZJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.