The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox M Stem (bencox Hip System) And Bencox Id Cemented Stem (with Centralizer) & Bencox Bone Plug.
| Device ID | K152084 |
| 510k Number | K152084 |
| Device Name: | Bencox M Stem (Bencox Hip System) And Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | CORENTEC CO., LTD 12, YEONGSANHONG 1-GIL, IPJANG-MYEON Cheonan-si, KR 331-822 |
| Contact | J S Daniel |
| Correspondent | J S Daniel CORENTEC CO., LTD 8F CHUNGHO TOWER, 483, GANGNAM-DAERO Seocho Gu, Seoul, KR 137-040 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2016-04-29 |
| Summary: | summary |