Skip to the page
Get started – free

Data / Medical devices / Thailand / G Surgical Co., Ltd.

G Surgical Co., Ltd.: FDA-registered device maker in BANGKOK Krung Thep Maha Nakhon, Thailand, 9 510(k) clearances

G Surgical Co., Ltd. is registered with the FDA (registration 3006378738) in BANGKOK Krung Thep Maha Nakhon, Thailand. It lists 10 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 5, 2024. 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 G Surgical Co., Ltd.
FDA registration number
3006378738
Address
294/62 Nalin Avenue, Ramkamhaeng Road SAPANSUNG, BANGKOK Krung Thep Maha Nakhon, Thailand, 10240
Owner or operator
G SURGICAL LLC (9096480)
Roles
Complaint file establishment, Exporter to the US, Manufacturer
First device listed
January 9, 2007
Registered through
2026
Brand names listed
G Surgical Marksman MIS System, G Surgical Marksman Spinal Deformity System, G Surgical Marksman System, G Surgical OCT Spinal System, GPS Anterior Plate System, GPS Cervical Spacers, GPS Spacers, GPS, G Surgical Pedicle System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishmentaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishmentaccessdata.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
April 5, 2024K240737G Surgical Marksman MIS SystemNKBSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
February 9, 2023K230063G Surgical Marksman Spinal Deformity SystemNKBSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
April 23, 2021K210890GPS Cervical SpacersODPSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
December 17, 2019K193219G Surgical Marksman SystemNKBSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
December 19, 2017K171834G Surgical OCT Spinal SystemNKGSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
August 25, 2016K161516G Surgical Marksman MIS SystemNKBSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
April 10, 2015K142456GPS SpacersODPSubstantially EquivalentG Surgical, LLCaccessdata.fda.gov
January 12, 2011K103070GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +KWQSubstantially EquivalentG Surgical Co., Ltd.accessdata.fda.gov
June 27, 2008K081041GPS, G SURGICAL PEDICLE SYSTEMMNHSubstantially EquivalentG Surgical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 5, 2024. 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.