FDA 510(k)

Airlock Centrolock 骨折固定植入系統

K 號：K192356 · 2019-12-14

決定日期2019-12-14

產品代碼HRS

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決定相當於

器材摘要

Airlock Centrolock Osteosynthesis Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Novastep. It received FDA 510(k) clearance on 2019-12-14 under 510(k) number K192356. 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 Airlock Centrolock Osteosynthesis Implant System?

Airlock Centrolock Osteosynthesis Implant System is a medical device that received FDA 510(k) clearance on 2019-12-14. The listed applicant is Novastep. The 510(k) number is K192356.

When did Airlock Centrolock Osteosynthesis Implant System receive FDA 510(k) clearance?

Airlock Centrolock Osteosynthesis Implant System received FDA 510(k) clearance on 2019-12-14, under 510(k) number K192356.

Who is the listed applicant for Airlock Centrolock Osteosynthesis Implant System?

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

What is the FDA product code for Airlock Centrolock Osteosynthesis Implant System?

The FDA product code for Airlock Centrolock Osteosynthesis Implant System is HRS.

其他以 Novastep 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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