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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 K233542
Device Name Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
Applicant
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg Im Breisgau,  DE D-79111
Applicant Contact Megan B Guilbault
Correspondent
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg Im Breisgau,  DE D-79111
Correspondent Contact Megan B Guilbault
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/03/2023
Decision Date 03/14/2024
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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