FDA 510(k)

MAGEC®系統

K 號：K201543 · 2020-07-30

申請人Nuvasive Specialized Orthopedics, Inc.

決定日期2020-07-30

產品代碼PGN

諮詢委員會或

決定相當於

器材摘要

MAGEC® System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K201543. The device is classified under product code PGN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MAGEC® System?

MAGEC® System is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K201543.

When did MAGEC® System receive FDA 510(k) clearance?

MAGEC® System received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201543.

Who is the listed applicant for MAGEC® System?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGEC® System?

The FDA product code for MAGEC® System is PGN.

其他以 Nuvasive Specialized Orthopedics, Inc. 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。

K230765精準踝關節救護系統 K220234精準內髓腔肢體延長系統 K202348外部遙控器 ERC 4P K200430Precice® 靈骨救護系統 K201567精準® 骨傳遞系統 K193016精準骨傳遞系統

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相關器械（代碼：PGN）

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。

K233593MAGEC脊椎支具及擴張系統Nuvasive Specialized Orthopedics, Incorporated K171791MAGEC®系統Nuvasive Specialized Orthopedics, Incorporated K160352MAGEC®脊椎支具及擴張系統Nuvasive Specialized Orthopedics, Inc.K161751MAGEC®脊椎支具及擴張系統Nuvasive Specialized Orthopedics, Inc.

官方來源

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