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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K050764
Device Name UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
Applicant
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Applicant Contact JOEL BATTS
Correspondent
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Correspondent Contact JOEL BATTS
Regulation Number888.3530
Classification Product Code
HRY  
Date Received03/24/2005
Decision Date 08/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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