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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 the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2024-11-08 under 510(k) 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. The listed applicant is Nvision Biomedical Technologies. The 510(k) number is K243231.

When did Trigon PEEK HA Wedges receive FDA 510(k) clearance?

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

Who is the listed applicant for Trigon PEEK HA Wedges?

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 PEEK HA Wedges?

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

Other records listing Nvision Biomedical Technologies as applicant

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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.K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision 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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