FDA 510(k) Application Details - K192168

Device Classification Name	More FDA Info for this Device
510(K) Number	K192168
Device Name	Idys ALIF ZP 3DTi
Applicant	CLARIANCE, SAS 18 rue Robespierre Beaurains 62217 FR Other 510(k) Applications for this Company
Contact	Fadwa Bahr 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	08/09/2019
Decision Date	11/04/2019
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