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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
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