FDA 510(k) Applications Submitted by Stryker Leibinger GmbH & Co. KG

FDA 510(k) Number Submission Date Device Name Applicant
K240651 03/07/2024 MRI Universal Stryker Leibinger GmbH & Co. KG
K231599 06/01/2023 Stryker MP, Mandible, HMMF and MMF AXS Screws Stryker Leibinger GmbH & Co. KG
K221855 06/27/2022 Universal CMF System Stryker Leibinger GmbH & Co. KG
K243491 11/12/2024 SternalPlate Expansion Stryker Leibinger GmbH & Co. KG
K220593 03/01/2022 Spine Guidance Software, Stryker Q Guidance System Stryker Leibinger GmbH & Co. KG
K240662 03/08/2024 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual T Stryker Leibinger GmbH & Co. KG
K241517 05/29/2024 Q Guidance System; Mako Spine System; Stryker Leibinger GmbH & Co. KG
K141430 05/30/2014 VARIAX DISTAL RADIUS PLATING SYSTEM Stryker Leibinger GmbH & Co. KG
K230733 03/16/2023 Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co. KG
K231208 04/27/2023 Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co. KG
K191916 07/17/2019 Stryker CMF MEDPOR Priority Customized Implant Kit Stryker Leibinger GmbH & Co. KG
K182425 09/06/2018 Universal Mesh - Sterile Stryker Leibinger GmbH & Co. KG
K241171 04/26/2024 Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories Stryker Leibinger GmbH & Co. KG
K083009 10/09/2008 ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 Stryker Leibinger GmbH & Co. KG
K233542 11/03/2023 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System Stryker Leibinger GmbH & Co. KG
K223767 12/15/2022 Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System Stryker Leibinger GmbH & Co. KG
K162341 08/22/2016 Stryker OrthoMap Precision Knee system Stryker Leibinger GmbH & Co. KG
K093108 10/01/2009 STRYKER BIPOLAR FORCEPS Stryker Leibinger GmbH & Co. KG


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