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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 K010434
Device Name OPTETRAK B-SERIES TOTAL KNEE SYSTEM
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact Lisa Simpson
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact Lisa Simpson
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/13/2001
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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