510(k) K042091 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOLOX DELTA CERAMIC HEADS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 25, 2005 |
| Received | Aug 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2009 | Biomet, Inc. Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number 12-115112.
A hip joint metal/ceramic/polymer s Terminated |
LZO | None listed |
| Jul 14, 2009 | Biomet, Inc. Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112.
A hip joint metal/ceramic/polymer semiconstrained cemen Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.