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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 K101994
Device Name APEX KNEE MODULAR TIBIA SYSTEM
Applicant
Omnlife Science
50 O'Connell Way
East Taunton,  MA  02718
Applicant Contact RADHIKA TAUNTON
Correspondent
Omnlife Science
50 O'Connell Way
East Taunton,  MA  02718
Correspondent Contact RADHIKA TAUNTON
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received07/15/2010
Decision Date 09/28/2010
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
Recalls CDRH Recalls
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