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 |