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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 K152170
Device Name Exactech Optetrak Logic Enhanced Assembly
Applicant
EXACTECH, INC.
2320 NW 66th CT
Gainesville,  FL  32653
Applicant Contact Patrick Hughes
Correspondent
EXACTECH, INC.
2320 NW 66th CT
Gainesville,  FL  32653
Correspondent Contact Patrick Hughes
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/04/2015
Decision Date 09/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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