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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 K102578
Device Name APEX PS KNEE SYSTEM
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 Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received09/08/2010
Decision Date 03/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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