510(k) K071243 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
METAL HEMI IMPLANT
| Applicant | Orthopro, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, May 23, 2007 |
| Received | May 3, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | OrthoPro LLC Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplas Terminated |
KWD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.