Prase-AP Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

GBS Commonwealth Co., Ltd.

The following data is part of a premarket notification filed by Gbs Commonwealth Co., Ltd. with the FDA for Prase-ap Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK202878
510k NumberK202878
Device Name:Prase-AP Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu,  KR 08507
ContactJimmy Kim
CorrespondentJimmy Kim
GBS Commonwealth Co., Ltd. C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu,  KR 08507
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-01-29

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