FDA 510(k)

IBS-B MIS Beveled Screw System

Número K: K231236 · 2023-07-27

Data da decisão2023-07-27

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IBS-B MIS Beveled Screw System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231236. 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 IBS-B MIS Beveled Screw System?

IBS-B MIS Beveled Screw System is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is In2bones USA, LLC. The 510(k) number is K231236.

When did IBS-B MIS Beveled Screw System receive FDA 510(k) clearance?

IBS-B MIS Beveled Screw System received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231236.

Who is the listed applicant for IBS-B MIS Beveled Screw System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBS-B MIS Beveled Screw System?

The FDA product code for IBS-B MIS Beveled Screw System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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