FDA 510(k)

REVCON (TM) Screw System

Número K: K223392 · 2023-02-28

Data da decisão2023-02-28

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

REVCON (TM) Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Voom Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K223392. 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 REVCON (TM) Screw System?

REVCON (TM) Screw System is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Voom Medical Devices, Inc.. The 510(k) number is K223392.

When did REVCON (TM) Screw System receive FDA 510(k) clearance?

REVCON (TM) Screw System received FDA 510(k) clearance on 2023-02-28, under 510(k) number K223392.

Who is the listed applicant for REVCON (TM) Screw System?

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

What is the FDA product code for REVCON (TM) Screw System?

The FDA product code for REVCON (TM) Screw System is HWC. This falls under the Cardiovascular category.

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