The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Lospa Ii Knee System (exult Knee Replacement System).
| Device ID | K200395 |
| 510k Number | K200395 |
| Device Name: | LOSPA II Knee System (EXULT Knee Replacement System) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Corentec Co., Ltd 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, KR 31056 |
| Contact | Sungwon Yang |
| Correspondent | Yoorim Bae Corentec Co., Ltd. Banpo-daero 20-gil, 33-2, Seocho Gu, Seoul, KR 06649 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800068942197 | K200395 | 000 |