FDA 510(k)

HammerTechTM Fixation System

Número K: K182684 · 2018-11-23

Data da decisão2018-11-23

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

HammerTechTM Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K182684. 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 HammerTechTM Fixation System?

HammerTechTM Fixation System is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K182684.

When did HammerTechTM Fixation System receive FDA 510(k) clearance?

HammerTechTM Fixation System received FDA 510(k) clearance on 2018-11-23, under 510(k) number K182684.

Who is the listed applicant for HammerTechTM Fixation System?

The FDA 510(k) record lists Fusion Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HammerTechTM Fixation System?

The FDA product code for HammerTechTM Fixation System is HWC. This falls under the Cardiovascular category.

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Dispositivos Relacionados (Código: HWC)

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Fonte oficial

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