510(k) K082996 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOLOX DELTA OPTION CERAMIC HEADS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 15, 2009 |
| Received | Oct 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082996
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2024 | Zimmer GmbH Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.
Item Number: 650-1066 Open, Classified |
LZO | None listed |
| Sep 12, 2024 | Zimmer GmbH Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.
Item Number: 650-1064 Open, Classified |
LZO | None listed |
| Jun 5, 2017 | Zimmer Biomet, Inc. CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 Terminated |
LZO | None listed |
| Jun 5, 2017 | Zimmer Biomet, Inc. CER BIOLOXD OPTION HD 32MM, model # 650-1056 Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.