FDA 510(k) Application Details - K202065

Device Classification Name	More FDA Info for this Device
510(K) Number	K202065
Device Name	DOLOMITE Anterior Cervical Stabilization System
Applicant	Astura Medical, LLC 4949 W Royal Ln. Irving, TX 75063 US Other 510(k) Applications for this Company
Contact	Parker Kelch 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	07/27/2020
Decision Date	10/26/2020
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