The following data is part of a premarket notification filed by Corentec Co.,ltd. with the FDA for Bencox Mirabo Z Cup Cortinium.
| Device ID | K210614 |
| 510k Number | K210614 |
| Device Name: | BENCOX Mirabo Z Cup Cortinium |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Corentec Co.,Ltd. 12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do Chungcheongnam-do, KR 31056 |
| Contact | Yoorim Bae |
| Correspondent | Yoorim Bae Corentec Co.,Ltd. 12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do Chungcheongnam-do, KR 31056 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2022-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806373854095 | K210614 | 000 |
| 08800068901385 | K210614 | 000 |
| 08800068901392 | K210614 | 000 |
| 08800068904300 | K210614 | 000 |
| 08800068904317 | K210614 | 000 |
| 08806373853982 | K210614 | 000 |
| 08806373853999 | K210614 | 000 |
| 08806373854002 | K210614 | 000 |
| 08806373854019 | K210614 | 000 |
| 08806373854026 | K210614 | 000 |
| 08806373854033 | K210614 | 000 |
| 08806373854040 | K210614 | 000 |
| 08806373854057 | K210614 | 000 |
| 08806373854064 | K210614 | 000 |
| 08806373854071 | K210614 | 000 |
| 08806373854088 | K210614 | 000 |
| 08800068904676 | K210614 | 000 |