Cleared Special

Stealthstation S8 Spine Software v1.3.0

K201189 · Medtronic Navigation, Inc. · Orthopedic
May 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201189 is an FDA 510(k) clearance for the Stealthstation S8 Spine Software v1.3.0, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on May 29, 2020, 28 days after receiving the submission on May 1, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K201189 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2020
Decision Date May 29, 2020
Days to Decision 28 days
Submission Type Special
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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