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FDA 510(k)

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement

K-Number: K231809 · 2023-10-20

ApplicantUlrich Medical USA
Decision Date2023-10-20
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement is a medical device manufactured by Ulrich Medical USA. It received FDA 510(k) clearance on 2023-10-20 under approval number K231809. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement?

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement is a medical device that received FDA 510(k) clearance on 2023-10-20. It is manufactured by Ulrich Medical USA. The 510(k) number is K231809.

When was Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement approved by the FDA?

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement received FDA 510(k) clearance on 2023-10-20, under approval number K231809.

What company makes Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement?

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement is manufactured by Ulrich Medical USA.

What is the FDA product code for Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement?

The FDA product code for Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement is PML.

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 K223274Momentum® MIS Posterior Spinal Fixation System K220696uCerv Flux-C 3D Porous Titanium Cervical Interbody K230614Cortium™

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Related Devices (Code: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.

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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