Navigation Module Of The Momentum System

Orthopedic Stereotaxic Instrument

Ulrich Medical USA

The following data is part of a premarket notification filed by Ulrich Medical Usa with the FDA for Navigation Module Of The Momentum System.

Pre-market Notification Details

Device IDK200845
510k NumberK200845
Device Name:Navigation Module Of The Momentum System
ClassificationOrthopedic Stereotaxic Instrument
Applicant ulrich Medical USA 18221 Edison Avenue Chesterfield,  MO  63005
ContactHans Stover
CorrespondentHans Stover
ulrich Medical USA 18221 Edison Avenue Chesterfield,  MO  63005
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-09-10

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