510(k) clearance

FRAXION Spinal Fixation System

FDA 510(k) source

510(k) number

K262091

Applicant

Ortler Global Tibbi Gerecler Anonim Sirketi

Decision date

Sep 17, 2026

Date received

Jun 22, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NKB

Device type

Thoracolumbosacral Pedicle Screw System

Device class

Class II

Regulation

21 CFR 888.3070

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Ankara, TR