FDA 510(k) Application Details - K192645

Device Classification Name	More FDA Info for this Device
510(K) Number	K192645
Device Name	TrigonÖ Ti Stand-Alone Wedge Fixation System
Applicant	Nvision Biomedical Technologies, Inc. 4754 Shavano Oak, Suite 101 San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Diana Langham Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2019
Decision Date	12/23/2019
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