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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 K143725
Device Name Consensus Knee System Modular Tibial Baseplate
Applicant
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Applicant Contact Matthew M Hills
Correspondent
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Correspondent Contact Matthew M Hills
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received12/29/2014
Decision Date 03/04/2015
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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