FDA 510(k) Application Details - K191748

Device Classification Name	More FDA Info for this Device
510(K) Number	K191748
Device Name	Genesys Spine Sacroiliac Joint Fusion System
Applicant	Genesys Spine 1250 South Capital of Texas Highway, Building 3 Suite 600 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	William W. Sowers 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	07/01/2019
Decision Date	09/26/2019
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