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FDA 510(k)

Trigon HA Wedge Fixation System

K-Number: K220197 · 2022-02-23

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2022-02-23
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trigon HA Wedge Fixation System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under approval number K220197. 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 Wedge Fixation System?

Trigon HA Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2022-02-23. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K220197.

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

Trigon HA Wedge Fixation System received FDA 510(k) clearance on 2022-02-23, under approval number K220197.

What company makes Trigon HA Wedge Fixation System?

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

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

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

Related Clinical Trials

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Other Devices by Nvision Biomedical Technologies, Inc.

K192645Trigon™ Ti Stand-Alone Wedge Fixation System K190380nvc K203445Trigon HA Stand-Alone Wedge Fixation System K202657Javelin Tailor's Bunion Fixation System K200428Multi-Drive Interference Screw System K201850Vector Hammertoe Correction System

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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. K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, 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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