FDA 510(k) Application Details - K234116

Device Classification Name	More FDA Info for this Device
510(K) Number	K234116
Device Name	Trigon Trigon HA Stand-Alone Wedge Fixation System
Applicant	Nvision Biomedical Technologies 4590 Lockhill Selma San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Analaura Villarreal Berain 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	12/27/2023
Decision Date	01/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review