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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 K242464
Device Name Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
Applicant
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  28031
Applicant Contact Victoria Baldock
Correspondent
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Victoria Baldock
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/19/2024
Decision Date 06/05/2025
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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