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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 K183533
Device Name Unity Total Knee System
Applicant
Corin U.S.A. Limited
12750 Citrus Park Ln.
Suite 120
Tampa,  FL  33625
Applicant Contact Lucinda Gerber
Correspondent
Corin U.S.A. Limited
12750 Citrus Park Ln.
Suite 120
Tampa,  FL  33625
Correspondent Contact Lucinda Gerber
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/19/2018
Decision Date 06/04/2019
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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