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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 K131472
Device Name APEX KNEE MODULAR TIBIA SYSTEM
Applicant
OMNI LIFE SCIENCE, INC.
50 O'CONNELL WAY
EAST TAUNTON,  MA  02718
Applicant Contact BRANDON MOLINA
Correspondent
OMNI LIFE SCIENCE, INC.
50 O'CONNELL WAY
EAST TAUNTON,  MA  02718
Correspondent Contact BRANDON MOLINA
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received05/22/2013
Decision Date 10/08/2013
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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