FDA 510(k) Application Details - K212126

Device Classification Name	More FDA Info for this Device
510(K) Number	K212126
Device Name	MediExpand Cervical Expandable VBR System
Applicant	CMF Medicon Surgical Inc. 11200 St. Johns Industrial Pkwy N, Suite 1 Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Matthias Alber Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2021
Decision Date	04/04/2022
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