Data / Medical devices / United States / G Surgical LLC
G Surgical LLC: FDA-registered device maker in Austin, TX, United States, 9 510(k) clearances
G Surgical LLC is registered with the FDA (registration 3009169872) in Austin, TX, United States. 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.
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- FDA registration number
- 3009169872
- Address
- 9433 Bee Cave Road Building 3, Suite 101-A, Austin, TX, United States, 78733
- Owner or operator
- G SURGICAL LLC (9096480)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- 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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 2024 | K240737 | G Surgical Marksman MIS System | NKB | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| February 9, 2023 | K230063 | G Surgical Marksman Spinal Deformity System | NKB | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| April 23, 2021 | K210890 | GPS Cervical Spacers | ODP | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| December 17, 2019 | K193219 | G Surgical Marksman System | NKB | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| December 19, 2017 | K171834 | G Surgical OCT Spinal System | NKG | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| August 25, 2016 | K161516 | G Surgical Marksman MIS System | NKB | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| April 10, 2015 | K142456 | GPS Spacers | ODP | Substantially Equivalent | G Surgical, LLC | accessdata.fda.gov |
| January 12, 2011 | K103070 | GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + | KWQ | Substantially Equivalent | G Surgical Co., Ltd. | accessdata.fda.gov |
| June 27, 2008 | K081041 | GPS, G SURGICAL PEDICLE SYSTEM | MNH | Substantially Equivalent | G Surgical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Posterior Cervical Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Tray, Surgical, Instrument
- All makers of Appliance, Fixation, Spinal Intervertebral Body
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.