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FDA PMA

Osseoanchored prostheses for the rehabilitation of transfemoral amputees

Número do PMA: P190009 · 2026-04-15

RequerenteIntegrum AB
Data da decisão2026-04-15
Número PMAP190009
Código do produtoPJY
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoOR

Resumo do dispositivo

Osseoanchored prostheses for the rehabilitation of transfemoral amputees is the device name listed in this FDA 510(k) record. The listed applicant is Integrum AB. It received FDA 510(k) clearance on 2026-04-15. The device is classified under product code PJY. It was reviewed by the OR advisory panel.

Perguntas frequentes

What is the Osseoanchored prostheses for the rehabilitation of transfemoral amputees?

Osseoanchored prostheses for the rehabilitation of transfemoral amputees is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Integrum AB.

When did Osseoanchored prostheses for the rehabilitation of transfemoral amputees receive FDA 510(k) clearance?

The clearance date for Osseoanchored prostheses for the rehabilitation of transfemoral amputees can be found in the official FDA records.

Who is the listed applicant for Osseoanchored prostheses for the rehabilitation of transfemoral amputees?

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

What is the FDA product code for Osseoanchored prostheses for the rehabilitation of transfemoral amputees?

The FDA product code for Osseoanchored prostheses for the rehabilitation of transfemoral amputees is PJY.

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Fonte oficial

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