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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 K141821
Device Name ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact THOMAS MCNAMARA
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact THOMAS MCNAMARA
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LPH  
Date Received07/07/2014
Decision Date 08/28/2014
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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