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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 K100542
Device Name CONSENSUS REVISION KNEE SYSTEM
Applicant
Consensus Orthopedics, Inc.
1115 Winfield Way
Suite 100
El Dorado Hills,  CA  95762 -9623
Applicant Contact LUKE ROSE
Correspondent
Consensus Orthopedics, Inc.
1115 Winfield Way
Suite 100
El Dorado Hills,  CA  95762 -9623
Correspondent Contact LUKE ROSE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/25/2010
Decision Date 06/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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