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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 K935773
Device Name EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
Applicant
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Applicant Contact TIM SEESE
Correspondent
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Correspondent Contact TIM SEESE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/03/1993
Decision Date 12/09/1994
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
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