Stryker Leibinger GmbH & Co KG

Country / Region:Germany (DE)Website:stryker.com

510(k) submissions

8

Latest clearance

2026-02-19

Product codes

1

OLO

Cited as predicate

17

Product areas

FDA product code distribution

510(k) submissions

8 total

Showing 1–8

K number	Device name	Product code	Class	Decision
K253623	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	OLO	Class 2	2026-02-19
K252871	Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories	OLO	Class 2	2026-02-06
K241517	Q Guidance System; Mako Spine System;	OLO	Class 2	2024-08-27
K241171	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	OLO	Class 2	2024-07-25
K240662	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	OLO	Class 2	2024-06-06
K233542	Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System	OLO	Class 2	2024-03-14
K223767	Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System	OLO	Class 2	2023-02-13
K220593	Spine Guidance Software, Stryker Q Guidance System	OLO	Class 2	2022-05-27

Company profile

Canonical name: Stryker Leibinger GmbH & Co KG
Country / Region: Germany(DE)
Address: Botzinger Strasse 39-41 Freiburg Baden-Wurttemberg, DE D-79111
Website: stryker.com

Predicate manufacturers

Companies whose devices this company cited as predicates

2

2 manufacturers

Stryker Leibinger GmbH & Co KG
DE
10
Mako Surgical Corp.
US
1

Citing manufacturers

Companies that cited this company's devices as predicates

5

5 manufacturers