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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K182462
Device Name Exactech Alteon Highly Polished Femoral Stem
Applicant
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Zach Sharrah
Correspondent
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Zach Sharrah
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY   KWZ   LWJ  
Date Received09/10/2018
Decision Date 11/08/2018
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
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