K261130

AccelFix Spinal Fixation System

510(k) number
K261130
Device name
AccelFix Spinal Fixation System
Applicant
L&K BIOMED Co., Ltd. KR
Product code
NKB — Thoracolumbosacral Pedicle Screw System
Decision date
2026-05-05
Date received
2026-04-06
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K261130.pdf

Official FDA record: K261130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.