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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
510(k) Number K173583
Device Name Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
Applicant
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Shing Jen Tai
Correspondent
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Shing Jen Tai
Regulation Number888.3353
Classification Product Code
OQI  
Subsequent Product Codes
LZO   MEH  
Date Received11/20/2017
Decision Date 03/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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