The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Lospa Tibial Base Plate.
| Device ID | K121037 |
| 510k Number | K121037 |
| Device Name: | LOSPA TIBIAL BASE PLATE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CORENTEC CO., LTD 11TH CHUNGHO TOWER 748-1 BANPO 1 DONG Seocho Gu, Seoul, KR 137-040 |
| Contact | J.s. Daniel |
| Correspondent | J.s. Daniel CORENTEC CO., LTD 11TH CHUNGHO TOWER 748-1 BANPO 1 DONG Seocho Gu, Seoul, KR 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 | 2012-04-05 |
| Decision Date | 2012-05-03 |
| Summary: | summary |