FDA 510(k)

Locking Plates and Screws Systems

Número K: K240958 · 2025-02-10

RequerenteHebei Ruihe Medical Devices Co., Ltd.

Data da decisão2025-02-10

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Locking Plates and Screws Systems is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Ruihe Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K240958. 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 Locking Plates and Screws Systems?

Locking Plates and Screws Systems is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Hebei Ruihe Medical Devices Co., Ltd.. The 510(k) number is K240958.

When did Locking Plates and Screws Systems receive FDA 510(k) clearance?

Locking Plates and Screws Systems received FDA 510(k) clearance on 2025-02-10, under 510(k) number K240958.

Who is the listed applicant for Locking Plates and Screws Systems?

The FDA 510(k) record lists Hebei Ruihe Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Locking Plates and Screws Systems?

The FDA product code for Locking Plates and Screws Systems is HRS.

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Fonte oficial

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