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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K122518
Device Name SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
Original Applicant
BM KOREA CO., LTD.
951 starbuck st. unit j
fullerton,  CA  92833
Original Contact priscilla chung
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received08/17/2012
Decision Date 02/15/2013
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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