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G Surgical Marksman MIS System

by G Surgical, LLC United States 510(k)

510(k) K161516 Product code NKB

Overview

The G Surgical Marksman MIS System is a posterior pedicle screw system used to stabilize the noncervical spine (T1-S2/Ilium). It consists of longitudinal rods, polyaxial screws, and fasteners.

The system is supplied non-sterile and is intended for single use. It is used in a percutaneous minimally invasive surgical approach with MIS instrumentation. The device received FDA 510(k) clearance under K-number K161516 and is classified under product code NKB.

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 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161516 Date25 Aug 2016ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • 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 is the G Surgical Marksman MIS System used for?

    The G Surgical Marksman MIS System is used to stabilize the noncervical spine from T1 to S2 and the ilium, providing spinal fixation in posterior pedicle screw applications during percutaneous minimally invasive surgical procedures.

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

    The system is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after a surgical procedure to ensure patient safety and device integrity.

  • What components make up the G Surgical Marksman MIS System?

    The system consists of longitudinal rods, polyaxial screws, and fasteners, which work together to provide spinal stabilization in the thoracic, lumbar, and sacral regions when used with MIS instrumentation.

  • What regulatory pathway was used for the G Surgical Marksman MIS System?

    The device received FDA 510(k) clearance under K-number K161516, demonstrating it is substantially equivalent to a legally marketed predicate device, and is classified under product code NKB.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K161516 24 fields · synced 22 Oct 2026