Neon3™ Universal OCT Spinal Stabilization

Posterior Cervical Screw System

ULRICH GMBH & CO. KG

The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Neon3™ Universal Oct Spinal Stabilization.

Pre-market Notification Details

Device IDK161032
510k NumberK161032
Device Name:Neon3™ Universal OCT Spinal Stabilization
ClassificationPosterior Cervical Screw System
Applicant ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 Ulm,  DE 89081
ContactChristoph Ulrich
CorrespondentHans Stover
ULRICH MEDICAL USA 18221 EDISON AVENUE Chesterfield,  MO  63005
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-13
Decision Date2016-12-22
Summary:summary

NIH GUDID Devices

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