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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
Model CS2 HIP STEM
Device Name CS2 HIP SYSTEM
Applicant
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way, suite 100
el dorado hills,  CA  95762
Contact matthew m hull
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received08/20/2012
Decision Date 11/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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