StealthStation S8 Spine Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251282 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 StealthStation S8 Spine Software is an image-guided surgical navigation system used for spinal procedures. It combines hardware, software, tracking algorithms, image data merging, and specialized instruments to provide clear visualization and surgical navigation.
The software is supplied by Medtronic Navigation, Inc. and is intended for use by qualified healthcare professionals. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has FDA 510(k) clearance with product code OLO.
Frequently asked questions
What is the StealthStation S8 Spine Software used for?
The StealthStation S8 Spine Software is an image-guided surgical navigation system designed for spinal procedures. It combines hardware, software, tracking algorithms, image data merging, and specialized instruments to provide clear visualization and surgical navigation during operations.
How is the StealthStation S8 Spine Software supplied?
The software is supplied by Medtronic Navigation, Inc. and is intended for use by qualified healthcare professionals. No specific information regarding sterility, single-use or reuse status, or storage conditions is provided in the device data.
What regulatory clearance does the StealthStation S8 Spine Software have?
The StealthStation S8 Spine Software has FDA 510(k) clearance with product code OLO. It was determined to be substantially equivalent through a traditional review process by the Neurology advisory committee.
What components are included in the StealthStation S8 Spine Software system?
The system combines hardware, software, tracking algorithms, image data merging capabilities, and specialized instruments to provide comprehensive visualization and surgical navigation for spinal procedures. The exact components and specifications are not detailed in the provided information.
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: StealthStation™ S8 navigation platform - Medtronic, StealthStation™ S8 navigation platform - Medtronic (CA), Medtronic StealthStation S8 Navigation System with Cranial, ENT & Spine ..., StealthStation™ S8 navigation platform - Medtronic (CA)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251282 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA 510(k) K251282 24 fields · synced Sep 26, 2026