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FDA 510(k)

Auxano® Wedge Fixation System

K-Number: K251791 · 2025-09-25

ApplicantAuxano Medical, LLC
Decision Date2025-09-25
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Auxano® Wedge Fixation System is a medical device manufactured by Auxano Medical, LLC. It received FDA 510(k) clearance on 2025-09-25 under approval number K251791. 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 Auxano® Wedge Fixation System?

Auxano® Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Auxano Medical, LLC. The 510(k) number is K251791.

When was Auxano® Wedge Fixation System approved by the FDA?

Auxano® Wedge Fixation System received FDA 510(k) clearance on 2025-09-25, under approval number K251791.

What company makes Auxano® Wedge Fixation System?

Auxano® Wedge Fixation System is manufactured by Auxano Medical, LLC.

What is the FDA product code for Auxano® Wedge Fixation System?

The FDA product code for Auxano® Wedge Fixation System is PLF.

Related Clinical Trials

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Other Devices by Auxano Medical, LLC

K231649Intraosseous Fusion Device 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

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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