510(k) clearance

7D Surgical System (10-0001)

FDA 510(k) source

510(k) number

K260403

Applicant

7D Surgical ULC

Decision date

Oct 19, 2026

Date received

Feb 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OLO

Device type

Orthopedic Stereotaxic Instrument

Device class

Class II

Regulation

21 CFR 882.4560

Advisory committee

Neurology

Statement or summary

Summary

Third party

N

Location

Toronto, CA