510(k) K063251 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 24, 2007 |
| Received | Oct 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 6; 00-7713-006-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00 Terminated |
LPH | None listed |
| May 30, 2018 | Zimmer Biomet, Inc. Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9; 00-7713-009-00 Terminated |
LPH | None listed |
| Jul 27, 2009 | Zimmer Inc. Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01.
Orthopedic implant used in total hip arthroplasty. Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.