510(k) K051411 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 29, 2005 |
| Received | May 31, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Hip Products
Item Number:
1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM
2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM
3) XL-105916 588500 RingLoc H Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.