FDA 510(k)

Fortilink™-C with TETRAfuse™ 3D Technology

Número K: K163673 · 2017-05-23

Data da decisão2017-05-23

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fortilink™-C with TETRAfuse™ 3D Technology is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K163673. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fortilink™-C with TETRAfuse™ 3D Technology?

Fortilink™-C with TETRAfuse™ 3D Technology is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K163673.

When did Fortilink™-C with TETRAfuse™ 3D Technology receive FDA 510(k) clearance?

Fortilink™-C with TETRAfuse™ 3D Technology received FDA 510(k) clearance on 2017-05-23, under 510(k) number K163673.

Who is the listed applicant for Fortilink™-C with TETRAfuse™ 3D Technology?

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

What is the FDA product code for Fortilink™-C with TETRAfuse™ 3D Technology?

The FDA product code for Fortilink™-C with TETRAfuse™ 3D Technology is ODP.

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Outros registros que listam Rti Surgical, Inc. como candidato(a)

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