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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 K113060
Device Name UNITY TOATAL KNEE SYSTEM
Applicant
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Applicant Contact LUCINDA GERBER
Correspondent
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Correspondent Contact LUCINDA GERBER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/14/2011
Decision Date 09/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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