COSY Cervicothoracic Occipital Rod-Screw System

Posterior Cervical Screw System

SIGNUS Medizintechnik GmbH

The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Cosy Cervicothoracic Occipital Rod-screw System.

Pre-market Notification Details

Device IDK220658
510k NumberK220658
Device Name:COSY Cervicothoracic Occipital Rod-Screw System
ClassificationPosterior Cervical Screw System
Applicant SIGNUS Medizintechnik GmbH Industriestraße 2 Alzenau,  DE 63755
ContactHolger Noss
CorrespondentHolger Noss
SIGNUS Medizintechnik GmbH Industriestraße 2 Alzenau,  DE 63755
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-11-18

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