SGM Femoral Nail System

FDA 510(k) K230456 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Substantially Equivalent

510(k) numberK230456

Submission

Device name
SGM Femoral Nail System
Applicant
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Changzhou, CN
Received
February 21, 2023
Decision date
June 30, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HSB

510(k)DeviceApplicantDecision
K261481Pangea Femur Reconstruction SystemHSB · Traditional Stryker GmbH06/29/2026SE
K261651Precice™ Max System and Precice™ Ankle Salvage SystemHSB · Special NuVasive Specialized Orthopedics06/18/2026SE
K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional Suzhou and Science & Technology Development Corp.06/18/2026SE
K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional Beijing Fule Science & Technology Development…06/17/2026SE
K253046HERA Interlocking Intramedullary Nailing SystemHSB · Traditional ZheJiang Decans Medical Devices Co., Ltd.06/16/2026SE
K260146Fitbone® Transport and Lengthening SystemHSB · Traditional Orthofix Srl05/19/2026SE
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional Orthofix Srl05/08/2026SE
K261043AUTOBAHN™ Nailing SystemHSB · Special Globus Medical, Inc.04/24/2026SE
K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
K252961Fusion FibFix NailHSB · Traditional Fusion Orthopedics USA, LLC03/18/2026SE

More from Fusion Orthopedics USA, LLC

510(k)DeviceDecision
K232394Internal Locking Plate and Screw Fixation SystemHRS · Traditional 12/15/2023SE
K223776PEEK Spinal Infusion CageMAX · Traditional 03/03/2023SE
K222031Spinal Inner Fixation SystemNKB · Traditional 10/28/2022SE

Questions and answers

When was SGM Femoral Nail System cleared by the FDA?

SGM Femoral Nail System (K230456) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 129 days after the submission was received.

What is the product code of K230456?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.