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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
Original Applicant
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way ste 100
el dorado hills,  CA  95762
Original 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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