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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 K122636
Model 427-03/04-080
Device Name REVELATION POROUS COATED HIP STEM, SIZE 8
Original Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Original Contact teffany hutto
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWZ   LZO   MBL  
Date Received08/29/2012
Decision Date 11/02/2012
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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