The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Uniglide Unicondylar Knee Prosthesis.
| Device ID | K050764 |
| 510k Number | K050764 |
| Device Name: | UNIGLIDE UNICONDYLAR KNEE PROSTHESIS |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel Batts |
| Correspondent | Joel Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-24 |
| Decision Date | 2005-08-24 |
| Summary: | summary |