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FDA 510(k)

Universal CMF System

K-Number: K221855 · 2022-11-09

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2022-11-09
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Universal CMF System is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2022-11-09 under approval number K221855. 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 Universal CMF System?

Universal CMF System is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K221855.

When was Universal CMF System approved by the FDA?

Universal CMF System received FDA 510(k) clearance on 2022-11-09, under approval number K221855.

What company makes Universal CMF System?

Universal CMF System is manufactured by Stryker Leibinger GmbH & Co KG.

What is the FDA product code for Universal CMF System?

The FDA product code for Universal CMF System is JEY.

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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.

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