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Data / Medical devices / South Korea / GS Medical Co., Ltd.

GS Medical Co., Ltd.: FDA-registered device maker in Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 19 510(k) clearances

GS Medical Co., Ltd. is registered with the FDA (registration 3005596514) in Heungdeok-gu, Cheongju-si Chungbuk, South Korea. It lists 39 device types. The FDA files 19 510(k) clearances under its listings, the newest dated October 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch GS Medical Co., Ltd.
FDA registration number
3005596514
Address
90, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28161
Owner or operator
GS Solutions, Inc. (9080979)
Roles
Manufacturer
First device listed
February 14, 2006
Registered through
2026
Brand names listed
3D Cervical Cage 3D Printed Trial, 3D Cervical Cage Trial, 3D Guide Inserter, 3D OLIF II Thread Inserter, 3D Printed Expandable PLIF Trial, 3D Printed OLIF II Trial, ACP, ALIF AnyPLUS PEEK Lumbar Cages and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
ArthroscopeHRX2Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Manufactureraccessdata.fda.gov
ClampHXD1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Driver, Surgical, PinGFC1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Manufactureraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Manufactureraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 2, 2026K261217AnyPlus II Spinal Fixation SystemNKBSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
September 17, 2026K254260The VEGA Cervical Screw SystemNKGSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
August 20, 2024K241738PYXIS 3D Titanium Cervical Cage systemODPSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
April 3, 2024K240350AnyPlus II Spinal Fixation SystemNKBSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
July 20, 2023K231808QUASAR Standalone ACIF SystemOVESubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
April 26, 2023K223868PYXIS 3D Titanium Cage SystemMAXSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
February 9, 2023K222041CYGNUS-C Standalone ACIF SystemOVESubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
July 27, 2022K221687Pegasus-X Expandable PLIF SystemMAXSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
October 28, 2021K211797TRACKER Plus Kyphoplasty SystemNDNSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
August 10, 2020K200592GS Medical AnyPlus PEEK Cage SystemODPSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
December 4, 2019K192335TRACKER Kyphoplasty SystemNDNSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
May 13, 2019K190170MVP Cervical Plate SystemKWQSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
October 23, 2017K172546AnyPlus® Spinal Fixation SystemNKBSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
June 24, 2016K153517AnyPlus® Cervical PEEK Cage SystemODPSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
April 18, 2014K131612ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGESMAXSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
October 17, 2011K111354GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)MAXSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
December 3, 2010K100516ANYPLUS PEEK CAGESOVDSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
January 25, 2010K091717ANY PLUS SPINAL FIXATION SYSTEMNKBSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov
March 8, 2006K053573GSS PEDICLE SCREW SYSTEMMNHSubstantially EquivalentGS Medical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.