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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 K936079
Device Name ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
Applicant
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Applicant Contact TIM SEESE
Correspondent
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Correspondent Contact TIM SEESE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/22/1993
Decision Date 09/07/1994
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
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