FDA 510(k) Application Details - K180695

Device Classification Name	More FDA Info for this Device
510(K) Number	K180695
Device Name	FBC 921 (ALIF)
Applicant	FBC Device ApS Viengevej 100 Risskov 8240 DK Other 510(k) Applications for this Company
Contact	Finn Bjarke Christensen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2018
Decision Date	07/12/2018
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