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Drill Guide +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240701

by Brainlab AG

Identifiers

510(k) Number
K240701 FDA 510(k)
FDA Product Code
OLO FDA 510(k)
Models / Variants
Drill Guide FDA 510(k)
Drill Bit FDA 510(k)
Spine & Trauma Navigation FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Drill Guide, Drill Bit, and Spine and Trauma Navigation system is a stereotaxic instrument designed for use as an intraoperative image-guided localization system. It is intended to enable both open and minimally invasive surgical procedures by linking a tracked freehand probe to virtual computer image space on a patient.

This device is supplied by Brainlab AG and has received FDA 510(k) clearance under K240701. It is classified as a Class II medical device under regulation 21 CFR 882.4560.

Frequently asked questions

What is the primary function of the Spine & Trauma Navigation system?

This system is designed as an intraoperative image-guided localization instrument. It functions by linking a tracked freehand probe to virtual computer image space on a patient, which assists surgeons during both open and minimally invasive surgical procedures.

What is the regulatory status of this Brainlab navigation system?

The Drill Guide, Drill Bit, and Spine and Trauma Navigation system has received FDA 510(k) clearance under K240701. It is classified as a Class II medical device under regulation 21 CFR 882.4560.

Who is the manufacturer of this surgical navigation equipment?

This device is manufactured by Brainlab AG, located in Munich, Germany. The company is the applicant for the FDA 510(k) clearance associated with this specific navigation and instrumentation system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Drill Guide; Drill Bit; Spine & Trauma Navigation by Brainlab AG | FDA ..., Drill Guide; Drill Bit; Spine & Trauma Navigation (K240701) — FDA 510 ..., Drill Guide; Drill Bit; Spine & Trauma Navigation… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (1)

  • FDA 510(k) K240701 24 fields · synced Sep 23, 2026