FDA 510(k) Application Details - K213815

Device Classification Name	More FDA Info for this Device
510(K) Number	K213815
Device Name	SiJoin«T3
Applicant	VGI Medical, Inc. 11651 87th Street Largo, FL 33773 US Other 510(k) Applications for this Company
Contact	Tov Vestgaarden 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	12/07/2021
Decision Date	03/29/2023
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