510(k) clearance

Freedom Nail Ankle Fusion System

FDA 510(k) source

510(k) number

K261189

Applicant

McGinley Orthopaedic Innovations

Decision date

Oct 19, 2026

Date received

Apr 10, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HSB

Device type

Rod, Fixation, Intramedullary And Accessories

Device class

Class II

Regulation

21 CFR 888.3020

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Casper, WY, US