FDA 510(k)

Anteralign 腰椎系統配備Titan nanoLOCK 表面技術

K 號：K214010 · 2022-04-12

決定日期2022-04-12

產品代碼MAX

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器材摘要

Anteralign Spinal System with Titan nanoLOCK Surface Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K214010. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anteralign Spinal System with Titan nanoLOCK Surface Technology?

Anteralign Spinal System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Medtronic Sofamor Danek USA. The 510(k) number is K214010.

When did Anteralign Spinal System with Titan nanoLOCK Surface Technology receive FDA 510(k) clearance?

Anteralign Spinal System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2022-04-12, under 510(k) number K214010.

Who is the listed applicant for Anteralign Spinal System with Titan nanoLOCK Surface Technology?

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

What is the FDA product code for Anteralign Spinal System with Titan nanoLOCK Surface Technology?

The FDA product code for Anteralign Spinal System with Titan nanoLOCK Surface Technology is MAX.

其他以 Medtronic Sofamor Danek USA 為申請人之記錄

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相關器械（代碼：MAX）

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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