The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Lospa Ii Knee System.
| Device ID | K192507 |
| 510k Number | K192507 |
| Device Name: | LOSPA II Knee 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 | J.s. Daniel |
| Correspondent | Min Jeong Lee Corentec Co., Ltd 33-2, Banpo-daero 20-gil, 33-2, Seocho Gu Seoul, KR 06649 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-12 |
| Decision Date | 2019-12-11 |