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Stryker Leibinger GmbH & Co KG

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261054 RibPlate SystemHRS2026-07-01 View
510(k) K254233 MEDPOR Customized Implant KitFWP2026-03-12 View
510(k) K253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air MotorOLO2026-02-19 View
510(k) K252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting AccessoriesOLO2026-02-06 View
510(k) K243491 SternalPlate ExpansionHRS2024-12-11 View
510(k) K241517 Q Guidance System; Mako Spine System;OLO2024-08-27 View
510(k) K241171 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 AccessoriesOLO2024-07-25 View
510(k) K240651 MRI UniversalJEY2024-07-12 View
510(k) K240662 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 Trigger Rotary HandpieceOLO2024-06-06 View
510(k) K233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance SystemOLO2024-03-14 View
510(k) K231599 Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL2023-08-24 View
510(k) K231208 Stryker Resorbable Fixation SystemHBW2023-08-14 View
510(k) K230733 Stryker Resorbable Fixation SystemJEY2023-08-05 View
510(k) K223767 Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemOLO2023-02-13 View
510(k) K221855 Universal CMF SystemJEY2022-11-09 View
510(k) K220593 Spine Guidance Software, Stryker Q Guidance SystemOLO2022-05-27 View
510(k) K191916 Stryker CMF MEDPOR Priority Customized Implant KitFWP2019-08-15 View
510(k) K182425 Universal Mesh - SterileGWO2018-11-06 View
510(k) K162341 Stryker OrthoMap Precision Knee systemOLO2016-10-12 View
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