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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sacroiliac joint fixation
510(k) Number K221047
Device Name SILO TFX MIS Sacroiliac Joint Fixation System
Applicant
Aurora Spine, Inc.
1930 Palomar Point Way, Suite #103
Carlsbad,  CA  92008
Applicant Contact Laszlo Garamszegi
Correspondent
MCRA LLC
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Samuel Pollard
Regulation Number888.3040
Classification Product Code
OUR  
Date Received04/08/2022
Decision Date 10/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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