FDA 510(k)

Endoskeleton™ Interbody Systems

K-Number: K251444 · 2025-09-04

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2025-09-04

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Endoskeleton™ Interbody Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251444. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoskeleton™ Interbody Systems?

Endoskeleton™ Interbody Systems is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K251444.

When did Endoskeleton™ Interbody Systems receive FDA 510(k) clearance?

Endoskeleton™ Interbody Systems received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251444.

Who is the listed applicant for Endoskeleton™ Interbody Systems?

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

What is the FDA product code for Endoskeleton™ Interbody Systems?

The FDA product code for Endoskeleton™ Interbody Systems is MAX.

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

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Related Devices (Code: MAX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.