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FDA 510(k)

Arthrex FibuLock Nail System

K-Number: K252196 · 2026-03-05

ApplicantArthrex, Inc.
Decision Date2026-03-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FibuLock Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) number K252196. 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 Arthrex FibuLock Nail System?

Arthrex FibuLock Nail System is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Arthrex, Inc.. The 510(k) number is K252196.

When did Arthrex FibuLock Nail System receive FDA 510(k) clearance?

Arthrex FibuLock Nail System received FDA 510(k) clearance on 2026-03-05, under 510(k) number K252196.

Who is the listed applicant for Arthrex FibuLock Nail System?

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

What is the FDA product code for Arthrex FibuLock Nail System?

The FDA product code for Arthrex FibuLock Nail System is HSB.

Other records listing Arthrex, Inc. as applicant

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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

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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