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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K072436
Device Name MEGA SPINE SYSTEM
Applicant
Bk Meditech, Co., Ltd.
25041 Farrier Circle
Laguna Hills,  CA  92653
Applicant Contact HENRY YANG
Correspondent
Bk Meditech, Co., Ltd.
25041 Farrier Circle
Laguna Hills,  CA  92653
Correspondent Contact HENRY YANG
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received08/30/2007
Decision Date 11/01/2007
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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