Trigon™ Ti 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™ Ti Stand-alone Wedge Fixation System.

Pre-market Notification Details

• Device ID: K192645
• 510k Number: K192645
• Device Name: Trigon™ Ti Stand-Alone Wedge Fixation System
• Classification: Bone Wedge
• Applicant: Nvision Biomedical Technologies, Inc. 4754 Shavano Oak, Suite 101 San Antonio, TX 78249
• Contact: Diana Langham
• Correspondent: Jeffrey Brittan; Watershed Idea Foundry 1815 Aston Ave, Suite 106 Carlsbad, CA 92008
• Product Code: PLF
• Subsequent Product Code: HRS
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-24
• Decision Date: 2019-12-23
• Summary: summary