510(k) K071535 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOLOX DELTA CERAMIC FEMORAL HEAD
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 19, 2007 |
| Received | Jun 5, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Ceramic Femoral Heads, various sizes, Item Nos. 00877504001
00877504002
00877504003
00877504004 Terminated |
LZO | None listed |
| Feb 20, 2015 | Zimmer Gmbh Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck l Terminated |
LZO | None listed |
| Nov 6, 2012 | Zimmer, Inc. Biolox delta Ceramic Femoral Head
Rx only, sterile Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.