Pegasus-X Expandable PLIF System

Intervertebral Fusion Device With Bone Graft, Lumbar

GS Medical Co. Ltd.

The following data is part of a premarket notification filed by Gs Medical Co. Ltd. with the FDA for Pegasus-x Expandable Plif System.

Pre-market Notification Details

Device IDK221687
510k NumberK221687
Device Name:Pegasus-X Expandable PLIF System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactSam Camp
CorrespondentBarry E. Sands
RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury,  MA  01913
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-10
Decision Date2022-07-27

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