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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 the device name listed in this FDA 510(k) record. The listed applicant is Auxano Medical, LLC. It received FDA 510(k) clearance on 2025-09-25 under 510(k) 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. The listed applicant is Auxano Medical, LLC. The 510(k) number is K251791.

When did Auxano® Wedge Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Auxano® Wedge Fixation System?

The FDA 510(k) record lists Auxano Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Auxano Medical, LLC as applicant

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.

K231649Intraosseous Fusion Device System

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 SurgicalK240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.K243231Trigon PEEK HA WedgesNvision Biomedical TechnologiesK234116Trigon 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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