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FDA 510(k)

Momentum® Posterior Spinal Fixation System

K-Number: K251719 · 2025-07-01

ApplicantUlrich Medical USA, Inc.
Decision Date2025-07-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Momentum® Posterior Spinal Fixation System is a medical device manufactured by Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2025-07-01 under approval number K251719. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Momentum® Posterior Spinal Fixation System?

Momentum® Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Ulrich Medical USA, Inc.. The 510(k) number is K251719.

When was Momentum® Posterior Spinal Fixation System approved by the FDA?

Momentum® Posterior Spinal Fixation System received FDA 510(k) clearance on 2025-07-01, under approval number K251719.

What company makes Momentum® Posterior Spinal Fixation System?

Momentum® Posterior Spinal Fixation System is manufactured by Ulrich Medical USA, Inc..

What is the FDA product code for Momentum® Posterior Spinal Fixation System?

The FDA product code for Momentum® Posterior Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Ulrich Medical USA, Inc.

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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