The following data is part of a premarket notification filed by Corentec Co.,ltd. with the FDA for Bencox Mirabo Cup System.
| Device ID | K220468 |
| 510k Number | K220468 |
| 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 Chungcheongnam-do Cheonan-si, KR 31056 |
| Contact | Yoorim Bae |
| Correspondent | Yoorim Bae Corentec Co.,Ltd. 12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si Chungcheongnam-do Cheonan-si, KR 31056 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800068901545 | K220468 | 000 |
| 08800068901163 | K220468 | 000 |
| 08800068901170 | K220468 | 000 |
| 08800068901460 | K220468 | 000 |
| 08800068901477 | K220468 | 000 |
| 08800068901484 | K220468 | 000 |
| 08800068901491 | K220468 | 000 |
| 08800068901507 | K220468 | 000 |
| 08800068901514 | K220468 | 000 |
| 08800068901521 | K220468 | 000 |
| 08800068901538 | K220468 | 000 |
| 08800068961419 | K220468 | 000 |