FDA 510(k)

I.T.S. 盆骨重建系統 (PRS RX & PRS Phoenix)

K 號：K210935 · 2022-08-31

決定日期2022-08-31

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. GmbH. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K210935. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is I.T.S. GmbH. The 510(k) number is K210935.

When did I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) receive FDA 510(k) clearance?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) received FDA 510(k) clearance on 2022-08-31, under 510(k) number K210935.

Who is the listed applicant for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

The FDA 510(k) record lists I.T.S. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

The FDA product code for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is HRS.

其他以 I.T.S. GmbH 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：HRS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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