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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
Original Applicant
1115 windfield way ste 100
el dorado hills,  CA  95762
Original Contact matthew m hull
Regulation Number888.3358
Classification Product Code
Subsequent Product Codes
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