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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, Uncemented
510(k) Number K090845
Device Name APEX ARC HIP STEM
Applicant
OMNI LIFE SCIENCE, INC.
175 PARAMOUNT DRIVE
SUITE 302
RAYNHAM,  MA  02767
Applicant Contact WILLIAM MCCALLUM
Correspondent
OMNI LIFE SCIENCE, INC.
175 PARAMOUNT DRIVE
SUITE 302
RAYNHAM,  MA  02767
Correspondent Contact WILLIAM MCCALLUM
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   MEH  
Date Received03/27/2009
Decision Date 04/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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