Yxoss CBR®

Plate, Bone

ReOss GmbH

The following data is part of a premarket notification filed by Reoss Gmbh with the FDA for Yxoss Cbr®.

Pre-market Notification Details

Device IDK192747
510k NumberK192747
Device Name:Yxoss CBR®
ClassificationPlate, Bone
Applicant ReOss GmbH Talstrasse 23 Filderstadt,  DE 70794
ContactMichael Peetz
CorrespondentViky Verna
confinis 15807 Glacier Court North Potomac,  MD  20878
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-06-17

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