FDA 510(k)

Placa óssea anatômica

Número K: K221088 · 2023-01-18

RequerenteDouble Medical Technology, Inc.

Data da decisão2023-01-18

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anatomic Bone Plate is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K221088. 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 Anatomic Bone Plate?

Anatomic Bone Plate is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221088.

When did Anatomic Bone Plate receive FDA 510(k) clearance?

Anatomic Bone Plate received FDA 510(k) clearance on 2023-01-18, under 510(k) number K221088.

Who is the listed applicant for Anatomic Bone Plate?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatomic Bone Plate?

The FDA product code for Anatomic Bone Plate is HRS.

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Fonte oficial

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