FDA 510(k)

Osteon Precision Milled Suprastructure

Número K: K221019 · 2022-07-05

RequerenteImplant Solutions Pty Ltd (Aka Osteon Medical)

Data da decisão2022-07-05

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Osteon Precision Milled Suprastructure is the device name listed in this FDA 510(k) record. The listed applicant is Implant Solutions Pty Ltd (Aka Osteon Medical). It received FDA 510(k) clearance on 2022-07-05 under 510(k) number K221019. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Osteon Precision Milled Suprastructure?

Osteon Precision Milled Suprastructure is a medical device that received FDA 510(k) clearance on 2022-07-05. The listed applicant is Implant Solutions Pty Ltd (Aka Osteon Medical). The 510(k) number is K221019.

When did Osteon Precision Milled Suprastructure receive FDA 510(k) clearance?

Osteon Precision Milled Suprastructure received FDA 510(k) clearance on 2022-07-05, under 510(k) number K221019.

Who is the listed applicant for Osteon Precision Milled Suprastructure?

The FDA 510(k) record lists Implant Solutions Pty Ltd (Aka Osteon Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteon Precision Milled Suprastructure?

The FDA product code for Osteon Precision Milled Suprastructure is NHA.

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Outros registros que listam Implant Solutions Pty Ltd (Aka Osteon Medical) como candidato(a)

K233083Osteon Precision Milled Suprastructure

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Fonte oficial

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