Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Yxoss CBR®

K-Number: K192747 · 2020-06-17

ApplicantReoss GmbH
Decision Date2020-06-17
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Yxoss CBR® is a medical device manufactured by Reoss GmbH. It received FDA 510(k) clearance on 2020-06-17 under approval number K192747. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yxoss CBR®?

Yxoss CBR® is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Reoss GmbH. The 510(k) number is K192747.

When was Yxoss CBR® approved by the FDA?

Yxoss CBR® received FDA 510(k) clearance on 2020-06-17, under approval number K192747.

What company makes Yxoss CBR®?

Yxoss CBR® is manufactured by Reoss GmbH.

What is the FDA product code for Yxoss CBR®?

The FDA product code for Yxoss CBR® is JEY.

Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K163579KLS Martin Individual Patient SolutionsKLS Martin L.P. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑