FDA 510(k) Application Details - K210402

Device Classification Name	More FDA Info for this Device
510(K) Number	K210402
Device Name	Curiteva Sacroiliac Joint Fusion System
Applicant	Curiteva, Inc. 25127 Will McComb Drive Tanner, AL 35671 US Other 510(k) Applications for this Company
Contact	Eric Linder Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2021
Decision Date	09/09/2021
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