FDA 510(k)

Outlet Sacroiliac Joint Fusion System

Número K: K181881 · 2018-10-03

Data da decisão2018-10-03

Código do produtoOUR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Outlet Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Sij Surgical. It received FDA 510(k) clearance on 2018-10-03 under 510(k) number K181881. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Outlet Sacroiliac Joint Fusion System?

Outlet Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2018-10-03. The listed applicant is Sij Surgical. The 510(k) number is K181881.

When did Outlet Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

Outlet Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2018-10-03, under 510(k) number K181881.

Who is the listed applicant for Outlet Sacroiliac Joint Fusion System?

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

What is the FDA product code for Outlet Sacroiliac Joint Fusion System?

The FDA product code for Outlet Sacroiliac Joint Fusion System is OUR.

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Dispositivos Relacionados (Código: OUR)

K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web Medical K251365OptumSI Implant SystemSi Solutions, LLC

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