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FDA 510(k)

Fusion FibFix Nail

K-Number: K252961 · 2026-03-18

ApplicantFusion Orthopedics USA, LLC
Decision Date2026-03-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fusion FibFix Nail is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics USA, LLC. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K252961. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion FibFix Nail?

Fusion FibFix Nail is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is Fusion Orthopedics USA, LLC. The 510(k) number is K252961.

When did Fusion FibFix Nail receive FDA 510(k) clearance?

Fusion FibFix Nail received FDA 510(k) clearance on 2026-03-18, under 510(k) number K252961.

Who is the listed applicant for Fusion FibFix Nail?

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

What is the FDA product code for Fusion FibFix Nail?

The FDA product code for Fusion FibFix Nail is HSB.

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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.

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