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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 a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-12-10 under approval 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. It is manufactured by Jeil Medical Corporation. The 510(k) number is K252826.

When was ARIX Femur Nail System approved by the FDA?

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

What company makes ARIX Femur Nail System?

ARIX Femur Nail System is manufactured by Jeil Medical Corporation.

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

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

Related Clinical Trials

NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED

Other Devices by Jeil Medical Corporation

K163308SMARTO K161746ARIX Hand System K161864ARIX Foot System K151468ARIX Wrist System K172008ARIX Humerus System K170705ARIX Wrist System

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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