Universal CMF System

Plate, Bone

Stryker Leibinger GmbH & Co. KG

The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Universal Cmf System.

Pre-market Notification Details

Device IDK221855
510k NumberK221855
Device Name:Universal CMF System
ClassificationPlate, Bone
Applicant Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg,  DE D-79111
ContactAmelia Kesti
CorrespondentAmelia Kesti
Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg,  DE D-79111
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-27
Decision Date2022-11-09

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.