FDA 510(k) Application Details - K203138

Device Classification Name	More FDA Info for this Device
510(K) Number	K203138
Device Name	FIREBIRD SI Fusion System
Applicant	Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 US Other 510(k) Applications for this Company
Contact	Jacki Koch 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	10/20/2020
Decision Date	11/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review