510(k) Report

FDA applicant

G Surgical, LLC

Austin, TX9 decisions2008–20240 recalls

FDA records 9 decisions for G Surgical, LLC (Austin, TX) from 2008 to 2024: 9 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “G Surgical Co., Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided G Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 12011: 12015: 12016: 12017: 12019: 12021: 12023: 12024: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — G Surgical, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like G Surgical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System4decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • NKGPosterior Cervical Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 22 predicates; 7 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161516G Surgical Marksman MIS SystemG Surgical, LLC · 20163cite it
  • K081041GPS, G Surgical Pedicle SystemG Surgical Co., Ltd. · 20082cite it
  • K193219G Surgical Marksman SystemG Surgical, LLC · 20191cites it
  • K142456GPS SpacersG Surgical, LLC · 20151cites it

What has FDA decided for it lately?

  • K240737G Surgical Marksman MIS SystemG Surgical, LLC · 2024
  • K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC · 2023
  • K210890GPS Cervical SpacersG Surgical, LLC · 2021
  • K193219G Surgical Marksman SystemG Surgical, LLC · 2019
  • K171834G Surgical OCT Spinal SystemG Surgical, LLC · 2017
  • K161516G Surgical Marksman MIS SystemG Surgical, LLC · 2016
  • K142456GPS SpacersG Surgical, LLC · 2015
  • K103070GPS TM, G Surgical Anterior Cervical Plate System +G Surgical Co., Ltd. · 2011

All 7 as G Surgical, LLC →All 2 as G Surgical Co., Ltd. →