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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 K121263
Device Name TAPER SET HIP SYSTEM RDP STEM
Original Applicant
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way ste 100
el dorado hills,  CA  95762
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWL   KWY   LZO  
Date Received04/26/2012
Decision Date 05/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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