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FDA 510(k)

Momentum® MIS Posterior Spinal Fixation System

K-Number: K223274 · 2022-11-28

ApplicantUlrich Medical USA
Decision Date2022-11-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Momentum® MIS Posterior Spinal Fixation System is a medical device manufactured by Ulrich Medical USA. It received FDA 510(k) clearance on 2022-11-28 under approval number K223274. 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® MIS Posterior Spinal Fixation System?

Momentum® MIS Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-11-28. It is manufactured by Ulrich Medical USA. The 510(k) number is K223274.

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

Momentum® MIS Posterior Spinal Fixation System received FDA 510(k) clearance on 2022-11-28, under approval number K223274.

What company makes Momentum® MIS Posterior Spinal Fixation System?

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

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

The FDA product code for Momentum® MIS 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

K181921Solidity Vertebral Body Replacement K191932Momentum™ Posterior Spinal Fixation System K200845Navigation Module of the Momentum System K220696uCerv Flux-C 3D Porous Titanium Cervical Interbody K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement K230614Cortium™

View all 7 devices →

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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