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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 K261060
Device Name Navigated LLIF Impactable Tracker
Applicant
Tyber Medical, LLC
83 S. Commerce Way
Suite 310
Bethlehem,  PA  18017
Applicant Contact Priscila Saraiva
Correspondent
Tyber Medical, LLC
83 S. Commerce Way
Suite 310
Bethlehem,  PA  18017
Correspondent Contact Priscila Saraiva
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/31/2026
Decision Date 05/29/2026
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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