ORTHONE by ONI, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Validate with FDA (Live)

Device Name

Manufacturer

Date Cleared

2000-08-18

(67 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K080048,K120701

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

N/A