FDA.reportPublic FDA data

510(k) K231808

Device
QUASAR Standalone ACIF System
Applicant
GS Medical Co., Ltd.
510(k) number
K231808
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-20
Date received
2023-06-20
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Seon Yeon Kim
Address
90, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu, Cheongju-Si KR 28161 28161

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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