510(k) clearance

Alians Forearm

FDA 510(k) source

510(k) number

K262649

Applicant

Newclip Technics

Decision date

Sep 28, 2026

Date received

Jul 30, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HRS

Device type

Plate, Fixation, Bone

Device class

Class II

Regulation

21 CFR 888.3030

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Haute-Goulaine, FR