Stryker Leibinger GmbH & Co. KG
Medical device manufacturer in Freiburg, DE.
35510(k) clearances
2PMA approvals
25recalls
Device types
- OLO Orthopedic Stereotaxic Instrument 10
- HRS Plate, Fixation, Bone 6
- JEY Plate, Bone 4
- GEI Electrosurgical, Cutting & Coagulation &… 2
- HAW Neurological Stereotaxic Instrument 2
- FWP Prosthesis, Chin, Internal 2
- GXP Methyl Methacrylate For Cranioplasty 1
- IXI Block, Beam-Shaping, Radiation Therapy 1
- IYE Accelerator, Linear, Medical 1
- DZE Implant, Endosseous, Root-Form 1
- KKY Material, Polytetrafluoroethylene Vitreous… 1
- GXN Plate, Cranioplasty, Preformed, Non-Alterable 1
- GWO Plate, Cranioplasty, Preformed, Alterable 1
- HBW Fastener, Plate, Cranioplasty 1
- DZL Screw, Fixation, Intraosseous 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261054 | RibPlate SystemHRS · Traditional | 07/01/2026SE |
| K254233 | MEDPOR Customized Implant KitFWP · Special | 03/12/2026SE |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…OLO · Traditional | 02/19/2026SE |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…OLO · Traditional | 02/06/2026SE |
| K243491 | SternalPlate ExpansionHRS · Special | 12/11/2024SE |
| K241517 | Q Guidance System; Mako Spine System;OLO · Traditional | 08/27/2024SE |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…OLO · Traditional | 07/25/2024SE |
| K240651 | MRI UniversalJEY · Traditional | 07/12/2024SE |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…OLO · Traditional | 06/06/2024SE |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…OLO · Traditional | 03/14/2024SE |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL · Traditional | 08/24/2023SE |
| K231208 | Stryker Resorbable Fixation SystemHBW · Traditional | 08/14/2023SE |
| K230733 | Stryker Resorbable Fixation SystemJEY · Traditional | 08/05/2023SE |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…OLO · Traditional | 02/13/2023SE |
| K221855 | Universal CMF SystemJEY · Traditional | 11/09/2022SE |
| K220593 | Spine Guidance Software, Stryker Q Guidance SystemOLO · Traditional | 05/27/2022SE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant KitFWP · Special | 08/15/2019SE |
| K182425 | Universal Mesh - SterileGWO · Special | 11/06/2018SE |
| K162341 | Stryker OrthoMap Precision Knee systemOLO · Traditional | 10/12/2016SE |
| K141430 | Variax Distal Radius Plating SystemHRS · Traditional | 07/18/2014SE |
| K133974 | Variax Distal Radius Plating SystemHRS · Traditional | 03/24/2014SE |
| K093108 | Stryker Bipolar ForcepsGEI · Traditional | 06/22/2010SE |
| K083009 | Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000OLO · Traditional | 02/19/2009SE |
| K052871 | Stryker Custom Ti ImplantGXN · Traditional | 12/16/2005SE |
| K043250 | Stryker Patient Specific Polymer ImplantKKY · Traditional | 04/15/2005SE |
| K041651 | Stryker Leibinger Skeletal Anchoring SystemDZE · Traditional | 09/30/2004SE |
| K040022 | Stryker Leibinger Universal Distal Radius SystemHRS · Traditional | 03/12/2004SE |
| K022579 | Stryker Navigation System-Knee ModuleHAW · Traditional | 06/02/2003SE |
| K023449 | Non-Invasive Patient Fixation SystemIYE · Traditional | 01/13/2003SE |
| K013775 | Twinfix Interfragmentary Compression Screw SystemHRS · Special | 01/08/2002SE |
| K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopyHAW · Traditional | 12/03/2001SE |
| K000594 | Locking Screw Mandibular Reconstruction PlateJEY · Traditional | 12/08/2000SE |
| K000349 | Motorized Micro Multileaf CollimatorIXI · Traditional | 05/03/2000SE |
| K000348 | Colorado Microdissection NeedleGEI · Traditional | 05/03/2000SE |
| K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded KitGXP · Traditional | 09/22/1999SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1885-2024 Class II | 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis…Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show… | 04/04/2024Open, Classified |
| Z-1785-2024 Class II | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction…Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a… | 03/29/2024Open, Classified |
| Z-1234-2023 Class II | Patient-Fitted Temporomandibular (TMJ) Reconstruction ProsthesisDevice was shipped without having regulatory approval. | 12/06/2022Open, Classified |
| Z-0715-2022 Class II | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the… | 12/29/2021Terminated |
| Z-1436-2021 Class II | DirectInject consists of a sterile dual paste system which is calcium phosphate based.…Inability for the user to inject the paste from the syringe into the target location. | 04/01/2021Terminated |
| Z-2915-2018 Class II | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2914-2018 Class II | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2913-2018 Class II | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2912-2018 Class II | AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2911-2018 Class II | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2910-2018 Class II | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2909-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2908-2018 Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2907-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2906-2018 Class II | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2905-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2904-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2903-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2902-2018 Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2901-2018 Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2900-2018 Class II | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2899-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-2898-2018 Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number…After a three year term, there is a potential for the external packaging (sterile barrier) to become… | 06/22/2018Terminated |
| Z-1150-2017 Class II | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set…An incorrect sterility status on the label, non-sterile products labeled as sterile | 01/03/2017Terminated |
| Z-1149-2017 Class II | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm…An incorrect sterility status on the label, non-sterile products labeled as sterile | 01/03/2017Terminated |