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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 K122512
Device Name CS2 HIP SYSTEM
Applicant
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Applicant Contact MATTHEW M HULL
Correspondent
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Correspondent Contact MATTHEW M HULL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received08/17/2012
Decision Date 11/05/2012
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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