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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 K973595
Device Name THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
Applicant
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Applicant Contact CRAIG CORRANCE
Correspondent
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Correspondent Contact CRAIG CORRANCE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/22/1997
Decision Date 12/19/1997
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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