The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox Mirabo Cup System.
| Device ID | K172806 |
| 510k Number | K172806 |
| Device Name: | 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 |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2017-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800017281438 | K172806 | 000 |
| 08800017281421 | K172806 | 000 |
| 08800017281414 | K172806 | 000 |
| 08800017281407 | K172806 | 000 |
| 08800017281391 | K172806 | 000 |