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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 K933494
Device Name EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
Original Applicant
EXACTECH, INC.
4613 n.w. 6th street, suite d
gainesville,  FL  32609
Original Contact timothy j seese
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/19/1993
Decision Date 03/10/1995
Decision (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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