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

Numéro K : K231809 · 2023-10-20

Date de décision2023-10-20

Code produitPML

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Ulrich Medical USA. The 510(k) number is K231809.

When did Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement receive FDA 510(k) clearance?

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 510(k) number K231809.

Who is the listed applicant 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 510(k) record lists Ulrich Medical USA as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Autres dossiers indiquant Ulrich Medical USA en tant que demandeur

K230614Cortium™K223274Momentum® MIS Posterior Spinal Fixation System K220696uCerv Flux-C 3D Porous Titanium Cervical Interbody K200845Navigation Module of the Momentum System K191932Momentum™ Posterior Spinal Fixation System K181921Solidity Vertebral Body Replacement

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Dispositifs connexes (Code : PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart K222789VADER® Pedicle System, G21 CementIcotec AG K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.

Source officielle

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