Spineart Navigation Instrument System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241644

Identifiers

510(k) Number: K241644 FDA 510(k)
FDA Product Code: OLO 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 Spineart Navigation Instrument System is a surgical tool used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws. It is a navigation compatible system that supports open, mini-open and percutaneous spinal approaches. The system provides seamless interaction between systems, allowing for tailored approaches, correction and stabilization. It integrates with intraoperative 3D imaging to improve surgical outcomes.

The Spineart Navigation Instrument System is supplied as a single system, with the specific model number K241644. It is designed for use in a surgical setting, with no stated sterility or reusability limitations. The system has received FDA 510K authorization, with a decision code of SESE, indicating substantial equivalence. The system is available for use in spinal surgery, with no specific storage or MRI safety limitations stated.

Frequently asked questions

What is the Spineart Navigation Instrument System used for?

The Spineart Navigation Instrument System is used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws, supporting open, mini-open, and percutaneous spinal approaches.

Is the Spineart Navigation Instrument System supplied sterile?

The system has no stated sterility or reusability limitations, but it is designed for use in a surgical setting.

What is the model number of the Spineart Navigation Instrument System?

The specific model number of the Spineart Navigation Instrument System is K241644.

Are there any storage limitations for the Spineart Navigation Instrument System?

There are no specific storage or MRI safety limitations stated for the Spineart Navigation Instrument 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: Solutions - Spineart, SPINEART Navigation Instrument System (K261205) - Innolitics, SPINEART Navigation Instrument System | FDA Radiology AI Device

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K241644	Class II	Active

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Manufacturer

Manufacturer: SpineArt SA

Sources (1)

FDA 510(k) K241644 24 fields · synced Sep 23, 2026