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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 K252871
Device Name Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
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 Received09/10/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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