Cleared Traditional

Stealth? Spine Clamps; ModuLeX? Shank Mounts

K242464 · Medtronic Navigation, Inc. · Orthopedic
Jun 2025
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K242464 is an FDA 510(k) clearance for the Stealth? Spine Clamps; ModuLeX? Shank Mounts, 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 June 5, 2025, 290 days after receiving the submission on August 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K242464 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2024
Decision Date June 05, 2025
Days to Decision 290 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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