FDA 510(k)

Lumbar Interbody Fusion System (OLLIF)

Número K: K173947 · 2018-07-25

RequerenteAdvanced Research Medical, LLC

Data da decisão2018-07-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lumbar Interbody Fusion System (OLLIF) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Research Medical, LLC. It received FDA 510(k) clearance on 2018-07-25 under 510(k) number K173947. 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 Lumbar Interbody Fusion System (OLLIF)?

Lumbar Interbody Fusion System (OLLIF) is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Advanced Research Medical, LLC. The 510(k) number is K173947.

When did Lumbar Interbody Fusion System (OLLIF) receive FDA 510(k) clearance?

Lumbar Interbody Fusion System (OLLIF) received FDA 510(k) clearance on 2018-07-25, under 510(k) number K173947.

Who is the listed applicant for Lumbar Interbody Fusion System (OLLIF)?

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

What is the FDA product code for Lumbar Interbody Fusion System (OLLIF)?

The FDA product code for Lumbar Interbody Fusion System (OLLIF) is MAX.

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Fonte oficial

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