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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 K252088
Device Name Firebird SI Navigation System
Applicant
Orthofix US LLC
3451 Plano Parkway
Lewisville,  TX  75056
Applicant Contact Kendal Moulton
Correspondent
Orthofix US LLC
3451 Plano Parkway
Lewisville,  TX  75056
Correspondent Contact Kendal Moulton
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/02/2025
Decision Date 10/31/2025
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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