510(k) K110555 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ARCOMXL ACTIVE ARTICULATION
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 24, 2011 |
| Received | Feb 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2016 | Zimmer Biomet, Inc. RingLoc ArComXL Highly Crosslinked Polyethylene Liners
ArComXL High Wall +3mm Liners Size 23 item XL-108323
ArComXL MaxRom +3mm Liners Size 23 item XL-108223 Terminated |
LPH | None listed |
| Dec 19, 2016 | Zimmer Biomet, Inc. Active Articulation ArComXL Polyethylene Bearings
Active Articulation ArComXL Bearings item XL-200152 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.