Stryker Leibinger GmbH & Co KG
Stryker Leibinger GmbH & Co KG holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2026, with 25 FDA device recalls on record.
Top product codes for Stryker Leibinger GmbH & Co KG
FDA recalls by Stryker Leibinger GmbH & Co KG
10 most recent of 25- Z-1885-2024 — 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
- Z-1785-2024 — Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
- Z-1234-2023 — Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Z-0715-2022 — MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- Z-1436-2021 — DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
- Z-2899-2018 — QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
- Z-2900-2018 — QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
- Z-2913-2018 — AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
- Z-2898-2018 — QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
- Z-2901-2018 — QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stryker Leibinger GmbH & Co KG
- K261054 — RibPlate System
- K254233 — MEDPOR Customized Implant Kit
- K253623 — Spine Guidance 5.4 Software +9 more
- K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
- K243491 — SternalPlate Expansion
- K241517 — Q Guidance System; Mako Spine System
- K241171 — Spine Guidance Software (Version 5.1) +4 more
- K240651 — MRI Universal
- K240662 — Spine Guidance Software (version 5.0) +8 more
- K233542 — Ortho Guidance Precision Knee Software +3 more
- K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws
- K231208 — Stryker Resorbable Fixation System
- K230733 — Stryker Resorbable Fixation System
- K223767 — Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
- K221855 — Universal CMF System
- K220593 — Spine Guidance Software, Stryker Q Guidance System
- K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit
- K182425 — Universal Mesh - Sterile
- K162341 — Stryker OrthoMap Precision Knee system
- K141430 — VARIAX DISTAL RADIUS PLATING SYSTEM
- K093108 — STRYKER BIPOLAR FORCEPS
- K083009 — ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
Data sourced from openFDA. This site is unofficial and independent of the FDA.