FDA 510(k) Application Details - K230026

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K230026
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Implanet, S.A. Technopole Bordeaux Montesquieu, Allee Francois Magendie Martillac 33650 FR Other 510(k) Applications for this Company
Contact	RΘgis Le Couδdic Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2023
Decision Date	03/28/2023
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