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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, porous uncemented
510(k) Number K102019
Device Name RESTORATION ACETABULAR WEDGE AUGMENTS
Applicant
HOWMEDICA OSTEONICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact KAREN ARIEMMA
Correspondent
HOWMEDICA OSTEONICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/19/2010
Decision Date 03/03/2011
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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