FDA 510(k)

Hand Trauma Screw System

Número K: K220723 · 2022-05-12

Data da decisão2022-05-12

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hand Trauma Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K220723. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hand Trauma Screw System?

Hand Trauma Screw System is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K220723.

When did Hand Trauma Screw System receive FDA 510(k) clearance?

Hand Trauma Screw System received FDA 510(k) clearance on 2022-05-12, under 510(k) number K220723.

Who is the listed applicant for Hand Trauma Screw System?

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

What is the FDA product code for Hand Trauma Screw System?

The FDA product code for Hand Trauma Screw System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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