FDA 510(k)

DePuy Synthes 2.0 mm Quick Insertion Screws

N.º K: K180541 · 2018-11-21

Fecha de decisión2018-11-21

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DePuy Synthes 2.0 mm Quick Insertion Screws is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K180541. 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.

Preguntas frecuentes

What is the DePuy Synthes 2.0 mm Quick Insertion Screws?

DePuy Synthes 2.0 mm Quick Insertion Screws is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K180541.

When did DePuy Synthes 2.0 mm Quick Insertion Screws receive FDA 510(k) clearance?

DePuy Synthes 2.0 mm Quick Insertion Screws received FDA 510(k) clearance on 2018-11-21, under 510(k) number K180541.

Who is the listed applicant for DePuy Synthes 2.0 mm Quick Insertion Screws?

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

What is the FDA product code for DePuy Synthes 2.0 mm Quick Insertion Screws?

The FDA product code for DePuy Synthes 2.0 mm Quick Insertion Screws is HWC. This falls under the Cardiovascular category.

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Fuente oficial

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