510(k) clearance

NOVIX Pedicle Screw System

FDA 510(k) source

510(k) number

K263062

Applicant

Tdm Co., Ltd.

Decision date

Oct 1, 2026

Date received

Sep 1, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Gwangju, KR