FDA 510(k) Application Details - K210470

Device Classification Name	More FDA Info for this Device
510(K) Number	K210470
Device Name	C-CURVE Interbody Fusion Device
Applicant	Medicrea International S. A. 5389 Route De Strasbourg - Vancia Rillieux-La-Pape 69140 FR Other 510(k) Applications for this Company
Contact	Karine Trogneux Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2021
Decision Date	09/03/2021
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