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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K100933
Device Name CONSENSUS CS2 PLUS ACETABULAR INSERT
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 Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received04/05/2010
Decision Date 10/06/2010
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
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