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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 K932690
Device Name EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
Applicant
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Applicant Contact TIMOTHY J SEESE
Correspondent
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Correspondent Contact TIMOTHY J SEESE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/03/1993
Decision Date 02/09/1995
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
Recalls CDRH Recalls
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