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FDA PMA

人工脊椎後部元件

PMA 核准號:P220002 · 2026-09-09

決定日期2026-09-09
PMA 編號P220002
產品代碼QWK
器械分類3 類
醫療專科U
諮詢委員會或

器材摘要

Prosthesis, posterior spinal elements is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2026-09-09. The device is classified under product code QWK. It was reviewed by the OR advisory panel.

常見問題

What is the Prosthesis, posterior spinal elements?

Prosthesis, posterior spinal elements is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is Premia Spine, Ltd..

When did Prosthesis, posterior spinal elements receive FDA 510(k) clearance?

The clearance date for Prosthesis, posterior spinal elements can be found in the official FDA records.

誰是假肢、後脊柱元件的列名申請人?

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

FDA產品代碼為後脊柱元件的義肢是什麼?

FDA產品代碼為Prosthesis, posterior spinal elements的後脊柱元件為QWK。

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官方來源

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