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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 cemented, osteophilic finish
510(k) Number K123604
Device Name ABG III MONOLITHIC HIP STEM
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact COLLEEN BURDEL
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact COLLEEN BURDEL
Regulation Number888.3353
Classification Product Code
MAY  
Subsequent Product Codes
LPH   LZO   MBL   MEH  
Date Received11/21/2012
Decision Date 08/16/2013
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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