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 a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2025-09-04 under approval 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. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K251444.

When was Endoskeleton Interbody Systems approved by the FDA?

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

What company makes Endoskeleton Interbody Systems?

Endoskeleton Interbody Systems is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for Endoskeleton Interbody Systems?

The FDA product code for Endoskeleton Interbody Systems is MAX.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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.