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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
510(k) Number K122015
Device Name DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Original Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate dr
mahwah,  NJ  07430
Original Contact christie pencinger
Regulation Number888.3510
Classification Product Code
KRO  
Date Received07/10/2012
Decision Date 02/22/2013
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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