GS Medical Co., Ltd. FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
The VEGA Cervical Screw System510(k)Sep 17, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 17, 2026
AnyPlus Navigated Instruments System510(k)Dec 6, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2024
PYXIS 3D Titanium Cervical Cage system510(k)Aug 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 20, 2024
AnyPlus II Spinal Fixation System510(k)Apr 3, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 3, 2024
QUASAR Standalone ACIF System510(k)Jul 20, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 20, 2023
PYXIS 3D Titanium Cage System510(k)Apr 26, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 26, 2023
CYGNUS-C Standalone ACIF System510(k)Feb 9, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 9, 2023
Pegasus-X Expandable PLIF System510(k)Jul 27, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 27, 2022
TRACKER Plus Kyphoplasty System510(k)Oct 28, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 28, 2021