FDA 510(k) Application Details - K210382

Device Classification Name	More FDA Info for this Device
510(K) Number	K210382
Device Name	Blustone Synergy Diamond SA Cervical System
Applicant	Blustone Synergy, LLC 5520 Ventana Ct Pueblo, CO 81005 US Other 510(k) Applications for this Company
Contact	Tom Gentry 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	02/09/2021
Decision Date	07/23/2021
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