FDA 510(k)

URIS Smart Path Implant System & Prosthetic

Número K: K230438 · 2023-12-29

Data da decisão2023-12-29

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

URIS Smart Path Implant System & Prosthetic is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K230438. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the URIS Smart Path Implant System & Prosthetic?

URIS Smart Path Implant System & Prosthetic is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Truabutment, Inc.. The 510(k) number is K230438.

When did URIS Smart Path Implant System & Prosthetic receive FDA 510(k) clearance?

URIS Smart Path Implant System & Prosthetic received FDA 510(k) clearance on 2023-12-29, under 510(k) number K230438.

Who is the listed applicant for URIS Smart Path Implant System & Prosthetic?

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

What is the FDA product code for URIS Smart Path Implant System & Prosthetic?

The FDA product code for URIS Smart Path Implant System & Prosthetic is DZE.

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

K243255URIS Long Implant & Abutments K241485TruAbutment DS; TruBase K231874AOT & T-L Abutment K213961TruAbutment DS, TruBase K203649TruAbutment DS, TruBase K202579TruAbutment DS, TruBase

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Fonte oficial

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