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FDA 510(k)

ARIX Femur Nail System

K-Number: K252826 · 2025-12-10

ApplicantJeil Medical Corporation
Decision Date2025-12-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARIX Femur Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-12-10 under 510(k) number K252826. 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 ARIX Femur Nail System?

ARIX Femur Nail System is a medical device that received FDA 510(k) clearance on 2025-12-10. The listed applicant is Jeil Medical Corporation. The 510(k) number is K252826.

When did ARIX Femur Nail System receive FDA 510(k) clearance?

ARIX Femur Nail System received FDA 510(k) clearance on 2025-12-10, under 510(k) number K252826.

Who is the listed applicant for ARIX Femur Nail System?

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

What is the FDA product code for ARIX Femur Nail System?

The FDA product code for ARIX Femur Nail System is HSB.

Other records listing Jeil Medical Corporation 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.

K252246Leforte MMF SystemK251431FIX-C PEEK ACIF SA SystemK243973FIX-L PEEK PLIF and T-PLIF SystemK242751ARIX Pectus Bar SystemK242247ARIX Femur Nail SystemK243915FIX-C 3D Ti ACIF System

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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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