510(k) clearance

Ntegrate Threaded Nail System

FDA 510(k) source

510(k) number

K261961

Applicant

Nvision Biomedical Technologies

Decision date

Oct 14, 2026

Date received

Jun 11, 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

San Antonio, TX, US