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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K112891
Device Name APEX REVISION KNEE SYSTEMS
Applicant
OMNI LIFE SCIENCE, INC.
50 O'CONNELL WAY
EAST TAUNTON,  MA  02718
Applicant Contact CHRISTINE NASSIF
Correspondent
OMNI LIFE SCIENCE, INC.
50 O'CONNELL WAY
EAST TAUNTON,  MA  02718
Correspondent Contact CHRISTINE NASSIF
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received09/30/2011
Decision Date 02/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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