510(k) clearance

CarboClear® Cervical Navigated Instruments

FDA 510(k) source

510(k) number

K263154

Applicant

CarboFix Orhtopedics , Ltd.

Decision date

Oct 9, 2026

Date received

Sep 9, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Herzeliya, IL