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FDA PMA

骨锚式義肢,用於轉股骨截肢者的復健

PMA 核准號:P190009 · 2026-04-15

申請人Integrum AB
決定日期2026-04-15
PMA 編號P190009
產品代碼PJY
器械分類3 類
醫療專科U
諮詢委員會或

器材摘要

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.

常見問題

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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官方來源

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