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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
Applicant
Bm Korea Co., Ltd.
951 St.arbuck St.
Unit J
Fullerton,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
Bm Korea Co., Ltd.
951 St.arbuck St.
Unit J
Fullerton,  CA  92833
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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