Prase PEEK Anterior Cervical Interbody Spacer

Intervertebral Fusion Device With Bone Graft, Cervical

GBS Commonwealth Co., Ltd.

The following data is part of a premarket notification filed by Gbs Commonwealth Co., Ltd. with the FDA for Prase Peek Anterior Cervical Interbody Spacer.

Pre-market Notification Details

Device IDK202872
510k NumberK202872
Device Name:Prase PEEK Anterior Cervical Interbody Spacer
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
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 CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-02-04

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