Varion Thoracolumbar Fixation System
K-Number: K260989 · 2026-05-15
Decision Date2026-05-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Varion Thoracolumbar Fixation System is a medical device manufactured by Kyocera Medical Technologies Inc. (KMTI). It received FDA 510(k) clearance on 2026-05-15 under approval number K260989. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Varion Thoracolumbar Fixation System?
Varion Thoracolumbar Fixation System is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Kyocera Medical Technologies Inc. (KMTI). The 510(k) number is K260989.
When was Varion Thoracolumbar Fixation System approved by the FDA?
Varion Thoracolumbar Fixation System received FDA 510(k) clearance on 2026-05-15, under approval number K260989.
What company makes Varion Thoracolumbar Fixation System?
Varion Thoracolumbar Fixation System is manufactured by Kyocera Medical Technologies Inc. (KMTI).
What is the FDA product code for Varion Thoracolumbar Fixation System?
The FDA product code for Varion Thoracolumbar Fixation System is NKB.
Related Devices (Code: NKB)
K253739SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline SystemGlobus Medical, Inc.
K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.
K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA
K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.
K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.