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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 K932776
Device Name CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
Applicant
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Applicant Contact TIMOTHY J SEESE
Correspondent
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Correspondent Contact TIMOTHY J SEESE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/08/1993
Decision Date 10/20/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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