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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 K111062
Device Name APEX KNEE SYSTEM, APEX ALL POLY TIBIA
Applicant
Omni Life Science, Inc.
50 O'Connell Way
Suite 10
East Taunton,  MA  02718
Applicant Contact CHRISTINE NASSIF
Correspondent
Omni Life Science, Inc.
50 O'Connell Way
Suite 10
East Taunton,  MA  02718
Correspondent Contact CHRISTINE NASSIF
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/18/2011
Decision Date 07/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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