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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
Applicant
HOWMEDICA OSTEONICS CORP.
325 CORPORATE DR
MAHWAH,  NJ  07430
Applicant Contact CHRISTIE PENCINGER
Correspondent
HOWMEDICA OSTEONICS CORP.
325 CORPORATE DR
MAHWAH,  NJ  07430
Correspondent Contact CHRISTIE PENCINGER
Regulation Number888.3510
Classification Product Code
KRO  
Date Received07/10/2012
Decision Date 02/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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