510(k) clearance

Symmetrix™ PX Spinal System

FDA 510(k) source

510(k) number

K262572

Applicant

Medtronic Sofamor Danek USA, Inc.

Decision date

Oct 29, 2026

Date received

Jul 27, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MAX

Device type

Intervertebral Fusion Device With Bone Graft, Lumbar

Device class

Class II

Regulation

21 CFR 888.3080

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Memphis, TN, US