FDA.reportPublic FDA data

510(k) K222041

Device
CYGNUS-C Standalone ACIF System
Applicant
GS Medical Co., Ltd.
510(k) number
K222041
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-09
Date received
2022-07-11
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sam Camp
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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