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G Surgical Marksman MIS System

by G Surgical, LLC United States 510(k)

510(k) K240737 Product code NKB

Overview

The G Surgical Marksman MIS System is a posterior pedicle screw system designed for spinal stabilization in the noncervical spine (T1–S2/Ilium). It consists of longitudinal rods, polyaxial screws, and fasteners to provide internal fixation for conditions such as spondylolisthesis, trauma (fracture or dislocation), and spinal stenosis. The system is engineered for minimally invasive surgery (MIS), enabling percutaneous access with specialized instrumentation. Its integrated screw-sleeve design and self-tapping threads enhance precision and ease of placement during surgical procedures.

The system is supplied as a sterile, single-use device for orthopedic use in spinal surgery. It includes 5.5mm bulleted rods, pre-bent in standard lengths, and is intended for use under fluoroscopic guidance. The G Surgical Marksman MIS System holds FDA 510(k) clearance (K240737) under the Special 510(k) Review pathway, classified under product code NKB. Compliance with MRI safety standards and proper storage conditions are critical for maintaining device integrity and performance.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK240737 Date5 Apr 2024ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from G Surgical LLC

See all devices from G Surgical LLC →

Questions

  • What conditions is the G Surgical Marksman MIS System designed to treat?

    The G Surgical Marksman MIS System is specifically engineered for spinal stabilization in the noncervical spine (T1 through S2 or ilium). It is intended for conditions such as spondylolisthesis, spinal trauma (including fractures or dislocations), and spinal stenosis. The system’s minimally invasive design allows for percutaneous access, reducing tissue disruption while providing secure fixation.

  • How is the G Surgical Marksman MIS System supplied, and is it reusable?

    The G Surgical Marksman MIS System is supplied as a sterile, single-use device. This ensures patient safety and maintains device integrity, as reuse could compromise sterility and performance. The system includes 5.5mm bulleted rods pre-bent in standard lengths, along with polyaxial screws and fasteners, all intended for one-time surgical use.

  • What makes the screw placement in this system more precise?

    The system features an integrated screw-sleeve design and self-tapping threads, which enhance precision during placement. These components work together to reduce the risk of misalignment or slippage, particularly during minimally invasive surgery (MIS). The design also streamlines the procedure, allowing surgeons to achieve accurate fixation under fluoroscopic guidance with less invasiveness.

  • Are there specific storage requirements for the G Surgical Marksman MIS System?

    Proper storage is critical to maintaining the device’s integrity and performance. The system must be stored in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Additionally, compliance with MRI safety standards is essential, as the system must be handled in accordance with guidelines to avoid interference or damage during MRI procedures.

  • What distinguishes the G Surgical Marksman MIS System from other spinal fixation systems?

    The G Surgical Marksman MIS System is uniquely designed for minimally invasive surgery (MIS), enabling percutaneous access with specialized instrumentation. Its self-tapping screws and integrated sleeve mechanism improve ease and precision of placement, reducing surgical time and tissue trauma. The system’s focus on noncervical spine stabilization (T1–S2/ilium) and fluoroscopy-guided application further differentiates it from traditional open-surgery systems.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K240737 24 fields · synced 22 Oct 2026