FDA 510(k)

Trigon Ti Stand-Alone Wedge Fixation System

K-Number: K192645 · 2019-12-23

ApplicantNvision Biomedical Technologies, Inc.

Decision Date2019-12-23

Product CodePLF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Trigon Ti Stand-Alone Wedge Fixation System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2019-12-23 under approval number K192645. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trigon Ti Stand-Alone Wedge Fixation System?

Trigon Ti Stand-Alone Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K192645.

When was Trigon Ti Stand-Alone Wedge Fixation System approved by the FDA?

Trigon Ti Stand-Alone Wedge Fixation System received FDA 510(k) clearance on 2019-12-23, under approval number K192645.

What company makes Trigon Ti Stand-Alone Wedge Fixation System?

Trigon Ti Stand-Alone Wedge Fixation System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for Trigon Ti Stand-Alone Wedge Fixation System?

The FDA product code for Trigon Ti Stand-Alone Wedge Fixation System is PLF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.