FDA 510(k)

Trigon PEEK HA Wedges

K-Number: K243231 · 2024-11-08

ApplicantNvision Biomedical Technologies

Decision Date2024-11-08

Product CodePLF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Trigon PEEK HA Wedges is a medical device manufactured by Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2024-11-08 under approval number K243231. 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 PEEK HA Wedges?

Trigon PEEK HA Wedges is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Nvision Biomedical Technologies. The 510(k) number is K243231.

When was Trigon PEEK HA Wedges approved by the FDA?

Trigon PEEK HA Wedges received FDA 510(k) clearance on 2024-11-08, under approval number K243231.

What company makes Trigon PEEK HA Wedges?

Trigon PEEK HA Wedges is manufactured by Nvision Biomedical Technologies.

What is the FDA product code for Trigon PEEK HA Wedges?

The FDA product code for Trigon PEEK HA Wedges is PLF.

Other Devices by Nvision Biomedical Technologies

K234116Trigon Trigon HA Stand-Alone Wedge Fixation System K250646Impact PEEK Union Nail System K242896Caliber Intramedullary Fixation System

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

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