510(k) K152084 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
| Applicant | Corentec Co., Ltd., Cheonan-Si, KR |
| Decision | Substantially Equivalent, Apr 29, 2016 |
| Received | Jul 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Teleflex Medical WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML
Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips Open, Classified |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.