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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 K153437
Device Name Apex Revision Knee System
Applicant
Omnilife Science
50 O'Connell Way
Suite 10
East Taunton,  MA  02718
Applicant Contact CHRISTINA ROVALDI
Correspondent
Omnilife Science
50 O'Connell Way
Suite 10
East Taunton,  MA  02718
Correspondent Contact CHRISTINA ROVALDI
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/27/2015
Decision Date 12/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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