FDA 510(k)

Headless Compression Screw System

Número K: K200259 · 2020-05-04

Data da decisão2020-05-04

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Headless Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Extremities, LLC. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K200259. 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 Headless Compression Screw System?

Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Osteocentric Extremities, LLC. The 510(k) number is K200259.

When did Headless Compression Screw System receive FDA 510(k) clearance?

Headless Compression Screw System received FDA 510(k) clearance on 2020-05-04, under 510(k) number K200259.

Who is the listed applicant for Headless Compression Screw System?

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

What is the FDA product code for Headless Compression Screw System?

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

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