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FDA PMA

Stimulator, bone growth, non-invasive

Número do PMA: P030034 · 2022-06-14

RequerenteOrthofix, Inc.
Data da decisão2022-06-14
Número PMAP030034
Código do produtoLOF
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoOR

Resumo do dispositivo

Stimulator, bone growth, non-invasive is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2022-06-14. The device is classified under product code LOF. It was reviewed by the OR advisory panel.

Perguntas frequentes

What is the Stimulator, bone growth, non-invasive?

Stimulator, bone growth, non-invasive is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is Orthofix, Inc..

When did Stimulator, bone growth, non-invasive receive FDA 510(k) clearance?

The clearance date for Stimulator, bone growth, non-invasive can be found in the official FDA records.

Who is the listed applicant for Stimulator, bone growth, non-invasive?

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

What is the FDA product code for Stimulator, bone growth, non-invasive?

The FDA product code for Stimulator, bone growth, non-invasive is LOF.

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