510(k) K131684 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOLOX(R) DELTA CERAMIC HEADS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 10, 2013 |
| Received | Jun 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2017 | Zimmer Biomet, Inc. DELTA CER FEM HD 32/0MM T1
Product Usage:
For use in hip arthroplasty Terminated |
LZO | None listed |
| Jun 30, 2017 | Zimmer Biomet, Inc. JUGGERKNOT 2.9MM 2 #2 MB
Product Usage:
For use in hip arthroplasty Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.