K-number	K192645
Device name	Trigon Ti Stand-Alone Wedge Fixation System
Applicant	Nvision Biomedical Technologies, Inc.
Product code	PLF
Device class	Class II
Decision date	Dec 23, 2019
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Trigon Ti Stand-Alone Wedge Fixation System

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Trigon Ti Stand-Alone Wedge Fixation System