FDA 510(k)

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology

Número K: K172343 · 2017-10-23

Data da decisão2017-10-23

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fortilink® Interbody Fusion (IBF) System 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 2017-10-23 under 510(k) number K172343. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology?

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K172343.

When did Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology receive FDA 510(k) clearance?

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172343.

Who is the listed applicant for Fortilink® Interbody Fusion (IBF) System 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® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology?

The FDA product code for Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology is MAX.

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

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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