FDA 510(k)

Stealth Spine Clamps; ModuLeX Shank Mounts

K-Number: K242464 · 2025-06-05

Decision Date2025-06-05

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Stealth Spine Clamps; ModuLeX Shank Mounts is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2025-06-05 under approval number K242464. 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 Stealth Spine Clamps; ModuLeX Shank Mounts?

Stealth Spine Clamps; ModuLeX Shank Mounts is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K242464.

When was Stealth Spine Clamps; ModuLeX Shank Mounts approved by the FDA?

Stealth Spine Clamps; ModuLeX Shank Mounts received FDA 510(k) clearance on 2025-06-05, under approval number K242464.

What company makes Stealth Spine Clamps; ModuLeX Shank Mounts?

Stealth Spine Clamps; ModuLeX Shank Mounts is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Stealth Spine Clamps; ModuLeX Shank Mounts?

The FDA product code for Stealth Spine Clamps; ModuLeX Shank Mounts is OLO.

Other Devices by Medtronic Navigation, Inc.

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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.