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FDA 510(k)

StealthStation S8 Spine Software

K-Number: K251282 · 2025-10-17

ApplicantMedtronic Navigation, Inc.
Decision Date2025-10-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation S8 Spine Software is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2025-10-17 under approval number K251282. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthStation S8 Spine Software?

StealthStation S8 Spine Software is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K251282.

When was StealthStation S8 Spine Software approved by the FDA?

StealthStation S8 Spine Software received FDA 510(k) clearance on 2025-10-17, under approval number K251282.

What company makes StealthStation S8 Spine Software?

StealthStation S8 Spine Software is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation S8 Spine Software?

The FDA product code for StealthStation S8 Spine Software is OLO.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Other Devices by Medtronic Navigation, Inc.

K162604Cranial Reducing Tubes K153660StealthStation System with Cranial Software K153555EM ENT Navigated Suctions K153247Fusion Compact Navigation System K170018StealthStationTM S8 ENT Software K162655StealthConnect Remote Viewing, Planning and Collaboration System

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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