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STRYKER LEIBINGER GMBH & CO. KG

Last updated September 17, 2026

Information

Country: DE
Address: BOTZINGER STRASSE 39-41, FREIBURG Baden-Wurttemberg
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002821504
DUNS Number: —

Catalogue (22)

Device	Model / Reference	Registries	Class	Status
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System	K233542	FDA 510(k)	Class II	Active
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	FDA 510(k)	Class II	Active
Stryker OrthoMap Precision Knee system	K162341	FDA 510(k)	Class II	Active
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	FDA 510(k)	Class II	Active
Stryker Resorbable Fixation System	K230733	FDA 510(k)	Class II	Active
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories	K252871	FDA 510(k)	Class II	Active
Q Guidance System; Mako Spine System;	K241517	FDA 510(k)	Class II	Active
Stryker Bipolar Forceps	K093108	FDA 510(k)	Class II	Active
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	FDA 510(k)	Class II	Active
Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000	K083009	FDA 510(k)	Class II	Active
Universal Mesh - Sterile	K182425	FDA 510(k)	Class II	Active
MEDPOR Customized Implant Kit	K254233	FDA 510(k)	Class II	Active
Universal CMF System	K221855	FDA 510(k)	Class II	Active
Stryker Resorbable Fixation System	K231208	FDA 510(k)	Class II	Active
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System	K223767	FDA 510(k)	Class II	Active
Stryker CMF MEDPOR Priority Customized Implant Kit	K191916	FDA 510(k)	Class II	Active
Stryker MP, Mandible, HMMF and MMF AXS Screws	K231599	FDA 510(k)	Class II	Active
SternalPlate Expansion	K243491	FDA 510(k)	Class II	Active
MRI Universal	K240651	FDA 510(k)	Class II	Active
Variax Distal Radius Plating System	K141430	FDA 510(k)	Class II	Active
Spine Guidance Software, Stryker Q Guidance System	K220593	FDA 510(k)	Class II	Active
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant	P130014	FDA PMA	Class III	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Stryker Leibinger US