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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 K171045
Device Name Exactech® Truliant™ Line Extensions
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Patrick Hughes
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Patrick Hughes
Regulation Number888.3560
Classification Product Code
Date Received04/07/2017
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls