Cleared Traditional

Momentum? Posterior Spinal Fixation System

K191932 · Ulrich Medical USA · Orthopedic

Oct 2019

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K191932 is an FDA 510(k) clearance for the Momentum? 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 October 2, 2019, 75 days after receiving the submission on July 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K191932 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2019
Decision Date	October 02, 2019
Days to Decision	75 days
Submission Type	Traditional
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.