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FDA 510(k) Application Details - K221047
Device Classification Name
More FDA Info for this Device
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 US
Other 510(k) Applications for this Company
Contact
Laszlo Garamszegi
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/2022
Decision Date
10/03/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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