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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 K112779
Device Name APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
Applicant
OMNLIFE SCIENCE
50 O'CONNELL WAY
SUITE 10
EAST TAUNTON,  MA  02718
Applicant Contact CHRISTINE NASSIF
Correspondent
OMNLIFE SCIENCE
50 O'CONNELL WAY
SUITE 10
EAST TAUNTON,  MA  02718
Correspondent Contact CHRISTINE NASSIF
Regulation Number888.3358
Classification Product Code
LPH  
Date Received09/26/2011
Decision Date 12/02/2011
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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