Trigon™ HA Stand-Alone Wedge Fixation System

Bone Wedge

Nvision Biomedical Technologies, Inc.

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc. with the FDA for Trigon™ Ha Stand-alone Wedge Fixation System.

Pre-market Notification Details

• Device ID: K223226
• 510k Number: K223226
• Device Name: Trigon™ HA Stand-Alone Wedge Fixation System
• Classification: Bone Wedge
• Applicant: Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249
• Contact: Diana Langham
• Correspondent: Analaura Villarreal-Berain; Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio, TX 78249
• Product Code: PLF
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-10-18
• Decision Date: 2022-12-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810005669337	K223226	000
00810005669320	K223226	000
00810005669313	K223226	000
00810005669306	K223226	000