Stryker Leibinger GmbH & Co KG - FDA 510(k) Cleared Devices
Recent clearances: MEDPOR Customized Implant Kit, Spine Guidance 5.4 Software, Spine Guidance 5.3 Software
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Leibinger GmbH & Co KG Orthopedic ✕
12 devices
Cleared
Feb 19, 2026
Spine Guidance 5.4 Software
Orthopedic
93d
Cleared
Feb 06, 2026
Spine Guidance 5.3 Software
Orthopedic
149d
Cleared
Dec 11, 2024
SternalPlate Expansion
Orthopedic
29d
Cleared
Aug 27, 2024
Q Guidance System
Orthopedic
90d
Cleared
Jul 25, 2024
Spine Guidance Software (Version 5.1)
Orthopedic
90d
Cleared
Jun 06, 2024
Spine Guidance Software (version 5.0)
Orthopedic
90d
Cleared
Mar 14, 2024
Ortho Guidance Precision Knee Software
Orthopedic
132d
Cleared
Feb 13, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software,...
Orthopedic
60d
Cleared
May 27, 2022
Spine Guidance Software, Stryker Q Guidance System
Orthopedic
87d
Cleared
Oct 12, 2016
Stryker OrthoMap Precision Knee system
Orthopedic
51d
Cleared
Jul 18, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
Orthopedic
49d
Cleared
Feb 19, 2009
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
Orthopedic
133d