The following data is part of a premarket notification filed by U&i Corp. with the FDA for Optigen Total Knee System.
| Device ID | K102367 |
| 510k Number | K102367 |
| Device Name: | OPTIGEN TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050 |
| Contact | Gyeong-je Kwon |
| Correspondent | Gyeong-je Kwon U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2010-12-08 |
| Summary: | summary |