FDA 510(k)

Robotic Graft Delivery Instruments

Número K: K230716 · 2023-07-18

Data da decisão2023-07-18

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Robotic Graft Delivery Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2023-07-18 under 510(k) number K230716. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Robotic Graft Delivery Instruments?

Robotic Graft Delivery Instruments is a medical device that received FDA 510(k) clearance on 2023-07-18. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K230716.

When did Robotic Graft Delivery Instruments receive FDA 510(k) clearance?

Robotic Graft Delivery Instruments received FDA 510(k) clearance on 2023-07-18, under 510(k) number K230716.

Who is the listed applicant for Robotic Graft Delivery Instruments?

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

What is the FDA product code for Robotic Graft Delivery Instruments?

The FDA product code for Robotic Graft Delivery Instruments is OLO.

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