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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 K211205
Device Name Prase-C Anterior Cervical Plate System
Applicant
Gbs Commonwealth Co., Ltd.
C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro
Geumcheon-Gu,  KR 08507
Applicant Contact Jimmy Kim
Correspondent
Gbs Commonwealth Co., Ltd.
C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Jimmy Kim
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/22/2021
Decision Date 08/12/2021
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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