Cleared Traditional

Navigation Module of the Momentum System

K200845 · Ulrich Medical USA · Orthopedic

Sep 2020

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K200845 is an FDA 510(k) clearance for the Navigation Module of the Momentum System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Ulrich Medical USA (Chesterfield, US). The FDA issued a Cleared decision on September 10, 2020, 163 days after receiving the submission on March 31, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K200845 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2020
Decision Date	September 10, 2020
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.