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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 K101976
Device Name INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
Applicant
Omni Life Science, Inc.
50 O'Connell Way
East Taunton,  MA  02718
Applicant Contact RADHIKA PONDICHERRY
Correspondent
Omni Life Science, Inc.
50 O'Connell Way
East Taunton,  MA  02718
Correspondent Contact RADHIKA PONDICHERRY
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/13/2010
Decision Date 09/14/2010
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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