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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/polymer, cemented
510(k) Number K120578
Device Name ACCOLADE II HIP STEM
Applicant
HOWMEDICA OSTEONICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact VALERIE GIAMBANCO
Correspondent
HOWMEDICA OSTEONICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact VALERIE GIAMBANCO
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWL   KWY   KWZ   LPH   LWJ  
LZO   MEH  
Date Received02/27/2012
Decision Date 03/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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