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FDA 510(k)

Trigon HA Stand-Alone Wedge Fixation System

K-Number: K193414 · 2020-02-25

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2020-02-25
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trigon HA Stand-Alone Wedge Fixation System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-02-25 under approval number K193414. 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 HA Stand-Alone Wedge Fixation System?

Trigon HA Stand-Alone Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2020-02-25. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K193414.

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

Trigon HA Stand-Alone Wedge Fixation System received FDA 510(k) clearance on 2020-02-25, under approval number K193414.

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

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

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

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

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Other Devices by Nvision Biomedical Technologies, Inc.

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Related Devices (Code: PLF)

K171327Tyber Medical Wedge SystemTyber Medical, LLC K162241TITAN 3-D™ Wedge SystemParagon 28 K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. K201314Restor3d Utility WedgeRestor3D, Inc.

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.

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