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 |