FDA 510(k)

OsteoCentric Bone Plate and Screw System

Número K: K190430 · 2019-03-22

Data da decisão2019-03-22

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OsteoCentric Bone Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Trauma. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K190430. 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 OsteoCentric Bone Plate and Screw System?

OsteoCentric Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Osteocentric Trauma. The 510(k) number is K190430.

When did OsteoCentric Bone Plate and Screw System receive FDA 510(k) clearance?

OsteoCentric Bone Plate and Screw System received FDA 510(k) clearance on 2019-03-22, under 510(k) number K190430.

Who is the listed applicant for OsteoCentric Bone Plate and Screw System?

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

What is the FDA product code for OsteoCentric Bone Plate and Screw System?

The FDA product code for OsteoCentric Bone Plate and Screw System is HWC. This falls under the Cardiovascular category.

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