510(k) clearance

Arthrex Beaming System

FDA 510(k) source

510(k) number

K262975

Applicant

Arthrex, Inc.

Decision date

Sep 25, 2026

Date received

Aug 26, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

HWC

Device type

Screw, Fixation, Bone

Device class

Class II

Regulation

21 CFR 888.3040

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Naples, FL, US