SpineArt Navigation Instrument System
FDA 510(k)Class II (US FDA 510(k))
by SpineArt SA
Identifiers
- 510(k) Number
- K183630 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 navigation device designed for thoracolumbar spinal procedures. It assists surgeons in accurately locating anatomical landmarks to facilitate precise placement of spinal screws during open, mini-open, or percutaneous approaches.
This system integrates with intraoperative 3D imaging platforms, such as the eCential Op.n PERLA® TL Navigation System, to enhance surgical precision. Supplied as a reusable medical device, it is intended for use in controlled surgical environments and has received FDA 510(k) clearance under the Traditional review pathway, with a classification under the Neurology advisory committee
Frequently asked questions
How is the SpineArt Navigation Instrument System used in spinal surgery, and what types of procedures does it support?
The SpineArt Navigation Instrument System is designed to assist surgeons in thoracolumbar spinal procedures by helping locate anatomical landmarks with precision. It supports open, mini-open, or percutaneous approaches, ensuring accurate placement of spinal screws. The system integrates with intraoperative 3D imaging platforms like the eCential Op.n PERLA® TL Navigation System to enhance surgical precision during these procedures.
Is the SpineArt Navigation Instrument System reusable or single-use, and what does this mean for its maintenance?
The SpineArt Navigation Instrument System is supplied as a reusable medical device. This means it is intended for repeated use in controlled surgical environments after proper cleaning, sterilization, and maintenance according to manufacturer guidelines. Reusability helps reduce waste but requires adherence to strict infection control protocols to ensure safety between procedures.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?
The SpineArt Navigation Instrument System received FDA clearance under the Traditional 510(k) review pathway, classified as substantially equivalent to a predicate device. The submission was reviewed by the Orthopedic Devices (OR) Review Panel under the Neurology advisory committee (NE) designation, though the actual advisory committee meeting was held under the Orthopedic Devices (OR) category. This process ensures compliance with U.S. regulatory standards for surgical navigation systems.
Can this system be used with other intraoperative imaging platforms, or is it limited to specific systems like the eCential Op.n PERLA® TL?
While the SpineArt Navigation Instrument System is explicitly designed to integrate with the eCential Op.n PERLA® TL Navigation System, its core function—assisting in precise anatomical landmark localization—could theoretically complement other 3D imaging platforms if compatibility is established. However, the manufacturer’s documentation and intended use focus on this specific integration, so clinicians should verify compatibility with their existing systems before adoption.
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: SPINEART Navigation Instrument System | FDA Radiology AI Device, Solutions - Spineart, K254158 FDA 510(k) - SPINEART Navigation Instrument System, K242933 FDA 510(k) - SPINEART Navigation Instrument System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183630 | Class II | Active |
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Manufacturer
- Manufacturer
- SpineArt SA
Sources (1)
- FDA 510(k) K183630 24 fields · synced Sep 19, 2026