FDA 510(k)

AccelFix Spinal Fixation System

K-Number: K261130 · 2026-05-05

Decision Date2026-05-05

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AccelFix Spinal Fixation System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2026-05-05 under approval number K261130. 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 AccelFix Spinal Fixation System?

AccelFix Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-05-05. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K261130.

When was AccelFix Spinal Fixation System approved by the FDA?

AccelFix Spinal Fixation System received FDA 510(k) clearance on 2026-05-05, under approval number K261130.

What company makes AccelFix Spinal Fixation System?

AccelFix Spinal Fixation System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for AccelFix Spinal Fixation System?

The FDA product code for AccelFix Spinal Fixation System is NKB.

Other Devices by L&K BIOMED Co., Ltd.

K260840BluEX Cervical Expandable Cage System K261112CastleLoc-P Anterior Cervical Plate System

Related Devices (Code: NKB)

K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) K253739SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline SystemGlobus Medical, Inc. 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.