FDA 510(k)

CARES 螺釘 - 留置橋梁和橋梁 (SRBB)

K 號：K201711 · 2020-12-08

決定日期2020-12-08

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

CARES Screw - Retained Bars and Bridges (SRBB) is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K201711. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARES Screw - Retained Bars and Bridges (SRBB)?

CARES Screw - Retained Bars and Bridges (SRBB) is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Medentika GmbH. The 510(k) number is K201711.

When did CARES Screw - Retained Bars and Bridges (SRBB) receive FDA 510(k) clearance?

CARES Screw - Retained Bars and Bridges (SRBB) received FDA 510(k) clearance on 2020-12-08, under 510(k) number K201711.

Who is the listed applicant for CARES Screw - Retained Bars and Bridges (SRBB)?

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

What is the FDA product code for CARES Screw - Retained Bars and Bridges (SRBB)?

The FDA product code for CARES Screw - Retained Bars and Bridges (SRBB) is NHA.

其他以 Medentika GmbH 為申請人之記錄

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相關器械（代碼：NHA）

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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官方來源

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