510(k) clearance

DynaNail Helix® Fixation System

FDA 510(k) source

510(k) number

K260995

Applicant

MedShape, Inc.

Decision date

Sep 23, 2026

Date received

Mar 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

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

Atlanta, GA, US