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FDA 510(k)

Fule Metallic Lockable Intramedullary Nail Systems

K-Number: K253155 · 2026-06-17

ApplicantBeijing Fule Science & Technology Development Co., Ltd.
Decision Date2026-06-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fule Metallic Lockable Intramedullary Nail Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253155. 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 Fule Metallic Lockable Intramedullary Nail Systems?

Fule Metallic Lockable Intramedullary Nail Systems is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K253155.

When did Fule Metallic Lockable Intramedullary Nail Systems receive FDA 510(k) clearance?

Fule Metallic Lockable Intramedullary Nail Systems received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253155.

Who is the listed applicant for Fule Metallic Lockable Intramedullary Nail Systems?

The FDA 510(k) record lists Beijing Fule Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fule Metallic Lockable Intramedullary Nail Systems?

The FDA product code for Fule Metallic Lockable Intramedullary Nail Systems is HSB.

Other records listing Beijing Fule Science & Technology Development Co., Ltd. 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.

K253151Fule Interbody Fusion Cage SystemK252730Fule Spinal Fixation System

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.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix SrlK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix 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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