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FDA 510(k)

Trigon Trigon HA Stand-Alone Wedge Fixation System

K-Number: K234116 · 2024-01-26

ApplicantNvision Biomedical Technologies
Decision Date2024-01-26
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trigon Trigon HA Stand-Alone Wedge Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K234116. 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 Trigon HA Stand-Alone Wedge Fixation System?

Trigon Trigon HA Stand-Alone Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Nvision Biomedical Technologies. The 510(k) number is K234116.

When did Trigon Trigon HA Stand-Alone Wedge Fixation System receive FDA 510(k) clearance?

Trigon Trigon HA Stand-Alone Wedge Fixation System received FDA 510(k) clearance on 2024-01-26, under 510(k) number K234116.

Who is the listed applicant for Trigon Trigon HA Stand-Alone Wedge Fixation System?

The FDA 510(k) record lists Nvision Biomedical Technologies as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: PLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLCK252254Osteotomy Wedge SystemSinaptic SurgicalK251791Auxano® Wedge Fixation SystemAuxano Medical, LLCK240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.K243231Trigon PEEK HA WedgesNvision Biomedical TechnologiesK231496TITAN 3-D Wedge SystemParagon 28, 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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