Cleared Traditional

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

K231809 · Ulrich Medical USA · Orthopedic

Oct 2023

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K231809 is an FDA 510(k) clearance for the Momentum? Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum? MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Ulrich Medical USA (Plano, US). The FDA issued a Cleared decision on October 20, 2023, 122 days after receiving the submission on June 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K231809 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2023
Decision Date	October 20, 2023
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.