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FDA 510(k)

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

K-Number: K242464 · 2025-06-05

ApplicantMedtronic Navigation, Inc.
Decision Date2025-06-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2025-06-05 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K242464.

When did Stealth™ Spine Clamps; ModuLeX™ Shank Mounts receive FDA 510(k) clearance?

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

Who is the listed applicant for Stealth™ Spine Clamps; ModuLeX™ Shank Mounts?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Medtronic Navigation, Inc. as applicant

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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