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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K162732
Device Name Exactech® Alteon® HA Femoral Stem
Applicant
EXACTECH INC
2320 NW 66TH COURT
GAINESVILLE,  FL  32653
Applicant Contact Thomas McNamara
Correspondent
EXACTECH INC
2320 NW 66TH COURT
GAINESVILLE,  FL  32653
Correspondent Contact Thomas McNamara
Regulation Number888.3353
Classification Product Code
MEH  
Date Received09/29/2016
Decision Date 04/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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