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Stryker Leibinger GmbH & Co KG FDA Approvals

0 new drug approvals and 16 device clearances on file. Matched by name to SYK.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
RibPlate System510(k)Jul 1, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
MEDPOR Customized Implant Kit510(k)Mar 12, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Mar 12, 2026
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 Motor510(k)Feb 19, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 19, 2026
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories510(k)Feb 6, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 6, 2026
SternalPlate Expansion510(k)Dec 11, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 11, 2024
Q Guidance System; Mako Spine System;510(k)Aug 27, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 27, 2024
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 Accessories510(k)Jul 25, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 25, 2024
MRI Universal510(k)Jul 12, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 12, 2024
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 Handpiece510(k)Jun 6, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 6, 2024
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System510(k)Mar 14, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 14, 2024
Stryker MP, Mandible, HMMF and MMF AXS Screws510(k)Aug 24, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 24, 2023
Stryker Resorbable Fixation System510(k)Aug 14, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 14, 2023
Stryker Resorbable Fixation System510(k)Aug 5, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 5, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System510(k)Feb 13, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 13, 2023
Universal CMF System510(k)Nov 9, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 9, 2022
Spine Guidance Software, Stryker Q Guidance System510(k)May 27, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 27, 2022

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