FDA 510(k)

Biolign® Roto-Loc 頸椎板系統

K 號：K200523 · 2020-04-30

決定日期2020-04-30

產品代碼KWQ

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器材摘要

Biolign® Roto-Loc Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K200523. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biolign® Roto-Loc Cervical Plate System?

Biolign® Roto-Loc Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. The 510(k) number is K200523.

When did Biolign® Roto-Loc Cervical Plate System receive FDA 510(k) clearance?

Biolign® Roto-Loc Cervical Plate System received FDA 510(k) clearance on 2020-04-30, under 510(k) number K200523.

Who is the listed applicant for Biolign® Roto-Loc Cervical Plate System?

The FDA 510(k) record lists Elite Surgical Supplies (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biolign® Roto-Loc Cervical Plate System?

The FDA product code for Biolign® Roto-Loc Cervical Plate System is KWQ.

相關器械（代碼：KWQ）

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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KWQ）

官方來源