TRACKER Plus Kyphoplasty System

Cement, Bone, Vertebroplasty

GS Medical Co. Ltd.

The following data is part of a premarket notification filed by Gs Medical Co. Ltd. with the FDA for Tracker Plus Kyphoplasty System.

Pre-market Notification Details

Device IDK211797
510k NumberK211797
Device Name:TRACKER Plus Kyphoplasty System
ClassificationCement, Bone, Vertebroplasty
Applicant GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactSam Camp
CorrespondentBarry Sands
RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury,  MA  01913
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-10
Decision Date2021-10-28

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