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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
510(k) Number K112897
Model A400
Device Name RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
Original Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
825 nicollet mall
ste 1820
minneapolis,  MN  55402
Original Contact david a teicher
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
LPH   LZO   OQI  
Date Received10/03/2011
Decision Date 06/13/2012
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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