510(k) K162127 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Bencox M Stem Lateralized & Bencox Mirabo Cup System
| Applicant | Corentec Co., Ltd., Cheonan, KR |
| Decision | Substantially Equivalent, Dec 5, 2016 |
| Received | Aug 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2017 | CORENTEC CO., LTD Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.