510(k) K101670 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
UNITED U2 BIPOLAR IMPLANT
| Applicant | United Orthopedic Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Oct 8, 2010 |
| Received | Jun 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Orthopedic Alliance LLC Bipolar Cap, ID26mm, OD42mm
Bipolar Cap, ID28mm, OD44mm
Bipolar Cap, ID28mm, OD46mm
Bipolar Cap, ID28mm, OD48mm
Bipolar Cap, ID28mm, OD50mm
Bipolar Cap, ID28mm, OD52mm
Bipolar Cap, ID28mm, OD54mm
Bipo Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.