The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Lospa Total Knee Replacement System.
| Device ID | K130673 |
| 510k Number | K130673 |
| Device Name: | LOSPA TOTAL KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CORENTEC CO., LTD 8TH CHUNGHO TOWER, 748-1 BANPO 1 DONG Seocho Gu, Seoul, KP 137-040 |
| Contact | J.s. Daniel |
| Correspondent | J.s. Daniel CORENTEC CO., LTD 8TH CHUNGHO TOWER, 748-1 BANPO 1 DONG Seocho Gu, Seoul, KP 137-040 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-04-15 |
| Summary: | summary |