510(k) clearance

The VEGA Cervical Screw System

FDA 510(k) source

510(k) number

K254260

Applicant

GS Medical Co., Ltd.

Decision date

Sep 17, 2026

Date received

Dec 29, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NKG

Device type

Posterior Cervical Screw System

Device class

Class II

Regulation

21 CFR 888.3075

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Cheongju, KR