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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K103070
Device Name GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
Applicant
G Surgical Co., Ltd.
152 Soi Ramkhamhaeng 138
Sapansung
Bangkok,  TH 10240
Applicant Contact DONALD GRAFTON
Correspondent
G Surgical Co., Ltd.
152 Soi Ramkhamhaeng 138
Sapansung
Bangkok,  TH 10240
Correspondent Contact DONALD GRAFTON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/18/2010
Decision Date 01/12/2011
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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