The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox M Stem Lateralized & Bencox Mirabo Cup System.
| Device ID | K162127 |
| 510k Number | K162127 |
| Device Name: | Bencox M Stem Lateralized & Bencox Mirabo Cup System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | CORENTEC CO., LTD 12, YEONGSANHONG 1-GIL, IPJANG-MYEON, SEOBUK GU Cheonan-si, KR 31056 |
| Contact | J. S. Daniel |
| Correspondent | J. S. Daniel CORENTEC CO., LTD 8F CHUNGHO TOWER, 483, GANGNAM-DAERO SEOCHO GU Seoul, KR 06541 |
| Product Code | LPH |
| 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 | 2016-08-01 |
| Decision Date | 2016-12-05 |
| Summary: | summary |