510(k) K111698 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
PROFEMUR(R) E CEMENTLESS HIP STEM
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Aug 19, 2011 |
| Received | Jun 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2012 | Wright Medical Technology Inc Hip Components:
INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225
INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226
TETE INOX "COLLEGIA" T 28/0 Terminated |
LPH | None listed |
| Oct 31, 2012 | Wright Medical Technology Inc Knee Components:
ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380
INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876
Terminated |
LPH | None listed |
| Oct 31, 2012 | Wright Medical Technology Inc Extremity Components:
PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985
PROTHES Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.