FDA 510(k) Application Details - K203780

Device Classification Name	More FDA Info for this Device
510(K) Number	K203780
Device Name	Harvester SI: Sacroiliac Fixation System
Applicant	Spinus International, Inc. 7200 North Interstate Highway 35, Building 1, Suite 1 Georgetown, TX 79626 US Other 510(k) Applications for this Company
Contact	Ron Oman 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	12/28/2020
Decision Date	03/23/2021
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