Cleared Traditional

StealthStation S8 Spine Software

K251282 · Medtronic Navigation, Inc. · Orthopedic
Oct 2025
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K251282 is an FDA 510(k) clearance for the StealthStation S8 Spine Software, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on October 17, 2025, 176 days after receiving the submission on April 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K251282 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2025
Decision Date October 17, 2025
Days to Decision 176 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLO — Orthopedic Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.

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