Cleared Special

Momentum? MIS Posterior Spinal Fixation System

K223274 · Ulrich Medical USA · Orthopedic

Nov 2022

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K223274 is an FDA 510(k) clearance for the Momentum? MIS Posterior Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Ulrich Medical USA (Chesterfield, US). The FDA issued a Cleared decision on November 28, 2022, 35 days after receiving the submission on October 24, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K223274 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2022
Decision Date	November 28, 2022
Days to Decision	35 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.