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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 a medical device manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-30 under approval 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. It is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K230456.

When was SGM Femoral Nail System approved by the FDA?

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

What company makes SGM Femoral Nail System?

SGM Femoral Nail System is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd..

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

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

Related Clinical Trials

NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT05523635 Post Market Clinical Evaluation of Gamma 4 COMPLETED NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT06368700 The HYALEX Pivotal Study RECRUITING

Other Devices by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K222031Spinal Inner Fixation System K232394Internal Locking Plate and Screw Fixation System K223776PEEK Spinal Infusion Cage

Related Devices (Code: HSB)

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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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