The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox Mirabo Cup Multi Hole.
| Device ID | K182221 |
| 510k Number | K182221 |
| Device Name: | Bencox Mirabo Cup Multi Hole |
| 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 |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-16 |
| Decision Date | 2019-04-01 |