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FDA 510(k)

SGM Femoral Nail System

K-Number: K230456 · 2023-06-30

ApplicantChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Decision Date2023-06-30
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SGM Femoral Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230456. 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 SGM Femoral Nail System?

SGM Femoral Nail System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K230456.

When did SGM Femoral Nail System receive FDA 510(k) clearance?

SGM Femoral Nail System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230456.

Who is the listed applicant for SGM Femoral Nail System?

The FDA 510(k) record lists Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SGM Femoral Nail System?

The FDA product code for SGM Femoral Nail System is HSB.

Other records listing Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. 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

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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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