FDA 510(k)

Internal Locking Plate and Screw Fixation System

Número K: K232394 · 2023-12-15

RequerenteChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Data da decisão2023-12-15

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Internal Locking Plate and Screw Fixation 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 2023-12-15 under 510(k) number K232394. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Internal Locking Plate and Screw Fixation System?

Internal Locking Plate and Screw Fixation System is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K232394.

When did Internal Locking Plate and Screw Fixation System receive FDA 510(k) clearance?

Internal Locking Plate and Screw Fixation System received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232394.

Who is the listed applicant for Internal Locking Plate and Screw Fixation 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 Internal Locking Plate and Screw Fixation System?

The FDA product code for Internal Locking Plate and Screw Fixation System is HRS.

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Fonte oficial

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