FDA 510(k) Application Details - K223190

Device Classification Name	More FDA Info for this Device
510(K) Number	K223190
Device Name	HiveÖ Standalone Cervical System
Applicant	NanoHive Medical LLC 12 Gill Street Suite 4500 Wobum, MA 01801 US Other 510(k) Applications for this Company
Contact	Ian Helmar 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	10/13/2022
Decision Date	12/12/2022
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