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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K243865
Device Name AERO MIS Facet Fusion System
Applicant
Aurora Spine
1930 Palomar Point Way Suite 103
Carlsbad,  CA  92009
Applicant Contact Laszlo Garamszegi
Correspondent
Medical Device Development
2390 Mission St.
Suite 8
San Francisco,  CA  94110
Correspondent Contact Jeremi Leasure
Classification Product Code
MRW  
Date Received12/17/2024
Decision Date 03/24/2025
Decision Substantially Equivalent (SESE)
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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