Medical Device Manufacturer · DE , Freiburg Im Breisgau

Stryker Leibinger GmbH & Co KG - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2009

Recent clearances: MEDPOR Customized Implant Kit, Spine Guidance 5.4 Software, Spine Guidance 5.3 Software

21
Total
21
Cleared
0
Denied

Stryker Leibinger GmbH & Co KG has 21 FDA 510(k) cleared medical devices. Based in Freiburg Im Breisgau, DE.

Latest FDA clearance: Mar 2026. Active since 2009. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Stryker Leibinger GmbH & Co KG Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Stryker Leibinger GmbH & Co KG

21 devices
1-21 of 21
Cleared Mar 12, 2026
MEDPOR Customized Implant Kit
K254233 · FWP
General & Plastic Surgery · 73d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Orthopedic · 93d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Orthopedic · 149d
Cleared Dec 11, 2024
SternalPlate Expansion
K243491 · HRS
Orthopedic · 29d
Cleared Aug 27, 2024
Q Guidance System
K241517 · OLO
Orthopedic · 90d
Cleared Jul 25, 2024
Spine Guidance Software (Version 5.1)
K241171 · OLO
Orthopedic · 90d
Cleared Jul 12, 2024
MRI Universal
K240651 · JEY
Dental · 127d
Cleared Jun 06, 2024
Spine Guidance Software (version 5.0)
K240662 · OLO
Orthopedic · 90d
Cleared Mar 14, 2024
Ortho Guidance Precision Knee Software
K233542 · OLO
Orthopedic · 132d
Cleared Aug 24, 2023
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · DZL
Dental · 84d
Cleared Aug 14, 2023
Stryker Resorbable Fixation System
K231208 · HBW
Neurology · 109d
Cleared Aug 05, 2023
Stryker Resorbable Fixation System
K230733 · JEY
Dental · 142d
Cleared Feb 13, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software,...
K223767 · OLO
Orthopedic · 60d
Cleared Nov 09, 2022
Universal CMF System
K221855 · JEY
Dental · 135d
Cleared May 27, 2022
Spine Guidance Software, Stryker Q Guidance System
K220593 · OLO
Orthopedic · 87d
Cleared Aug 15, 2019
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916 · FWP
General & Plastic Surgery · 29d
Cleared Nov 06, 2018
Universal Mesh - Sterile
K182425 · GWO
Neurology · 61d
Cleared Oct 12, 2016
Stryker OrthoMap Precision Knee system
K162341 · OLO
Orthopedic · 51d
Cleared Jul 18, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430 · HRS
Orthopedic · 49d
Cleared Jun 22, 2010
STRYKER BIPOLAR FORCEPS
K093108 · GEI
General & Plastic Surgery · 264d
Cleared Feb 19, 2009
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
K083009 · OLO
Orthopedic · 133d
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