510(k) clearance

Spinalogic Bone Growth Stimulator

FDA 510(k) source

510(k) number

K262721

Applicant

Djo, LLC

Decision date

Sep 29, 2026

Date received

Jul 31, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LOF

Device type

Stimulator, Bone Growth, Non-Invasive

Device class

Class II

Regulation

21 CFR 890.5870

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Carlsbad, CA, US