Medical Device Manufacturer · DE , Freiburg Im Breisgau

Stryker Leibinger GmbH & Co KG

21 submissions · 21 cleared · Since 2009
21
Total
21
Cleared
0
Denied

Stryker Leibinger GmbH & Co KG — FDA 510(k) Submissions

Stryker Leibinger GmbH & Co KG has submitted 21 FDA 510(k) premarket notifications since 2009, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Orthopedic Stereotaxic Instrument, Plate, Bone, Prosthesis, Chin, Internal, Plate, Fixation, Bone, Plate, Cranioplasty, Preformed, Alterable . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
MEDPOR Customized Implant Kit
K254233 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Mar 2026 73d
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 Motor
K253623 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2026 93d
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
K252871 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2026 149d
SternalPlate Expansion
K243491 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2024 29d
Q Guidance System; Mako Spine System;
K241517 · OLO Orthopedic Stereotaxic... · Orthopedic
Aug 2024 90d
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
K241171 · OLO Orthopedic Stereotaxic... · Orthopedic
Jul 2024 90d
MRI Universal
K240651 · JEY Plate, Bone · Dental
Jul 2024 127d
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 Handpiece
K240662 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 90d
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
K233542 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2024 132d
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · DZL Screw, Fixation,... · Dental
Aug 2023 84d
Stryker Resorbable Fixation System
K231208 · HBW Fastener, Plate,... · Neurology
Aug 2023 109d
Stryker Resorbable Fixation System
K230733 · JEY Plate, Bone · Dental
Aug 2023 142d
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
K223767 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2023 60d
Universal CMF System
K221855 · JEY Plate, Bone · Dental
Nov 2022 135d
Spine Guidance Software, Stryker Q Guidance System
K220593 · OLO Orthopedic Stereotaxic... · Orthopedic
May 2022 87d
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Aug 2019 29d
Universal Mesh - Sterile
K182425 · GWO Plate, Cranioplasty,... · Neurology
Nov 2018 61d
Stryker OrthoMap Precision Knee system
K162341 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2016 51d
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2014 49d
STRYKER BIPOLAR FORCEPS
K093108 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jun 2010 264d
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
K083009 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2009 133d
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