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 |