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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K170808
Device Name Unity Total Knee System
Applicant
Corin U.S.A. Limited
5670 W Cypress St., Suite C
Tampa,  FL  33607
Applicant Contact Rachel King
Correspondent
Corin U.S.A. Limited
5670 W Cypress St., Suite C
Tampa,  FL  33607
Correspondent Contact Rachel King
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/17/2017
Decision Date 07/13/2017
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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