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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K253623
Device Name 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
Applicant
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg Im Breisgau,  DE D-79111
Applicant Contact Andrea Wallen-Gerding
Correspondent
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg Im Breisgau,  DE D-79111
Correspondent Contact Andrea Wallen-Gerding
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/18/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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