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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K120353
Device Name SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
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 Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received02/06/2012
Decision Date 05/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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