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The Tracker / September 2026 / K254260

510(k) cleared

The VEGA Cervical Screw System

GS Medical Co., Ltd. · Sep 17, 2026 · K254260

FDA cleared the The VEGA Cervical Screw System from GS Medical Co., Ltd. on Sep 17, 2026 under K254260, a traditional 510(k). The device falls under product code NKG, Posterior Cervical Screw System, regulated at 21 CFR 888.3075 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 29, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GS Medical Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K262202 (Cerasmart Forte), K262828 (KHEIRON® Spinal Fixation System, including patient specific K-ROD), DEN250043 (Qoramatic Automated Stool Management), K261500 (KBA3D (v2.4.0)).

Questions & Answers

What did FDA clear under K254260?

K254260 is the FDA 510(k) for The VEGA Cervical Screw System, submitted by GS Medical Co., Ltd.. FDA's decision date was Sep 17, 2026, under product code NKG (Posterior Cervical Screw System).

Who makes the The VEGA Cervical Screw System?

GS Medical Co., Ltd., based in Cheongju, is the applicant of record for K254260.

How long did the K254260 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 17, 2026, 262 days later.

← All decisions in September 2026