FDA 510(k) Application Details - K211111

Device Classification Name	More FDA Info for this Device
510(K) Number	K211111
Device Name	SureMAX-SA Cervical Standalone System
Applicant	Additive Implants, Inc 3101 E. Shea Blvd, Suite 122 Phoenix, AZ 85028 US Other 510(k) Applications for this Company
Contact	Jeff Horn 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	04/14/2021
Decision Date	07/16/2021
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