FDA 510(k)

科迪亞克腰椎間隔系統

K 號：K230851 · 2023-05-26

決定日期2023-05-26

產品代碼MAX

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決定相當於

器材摘要

Kodiak Lumbar Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Met One Technologies, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230851. 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 Kodiak Lumbar Spacer System?

Kodiak Lumbar Spacer System is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Met One Technologies, LLC. The 510(k) number is K230851.

When did Kodiak Lumbar Spacer System receive FDA 510(k) clearance?

Kodiak Lumbar Spacer System received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230851.

Who is the listed applicant for Kodiak Lumbar Spacer System?

The FDA 510(k) record lists Met One Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kodiak Lumbar Spacer System?

The FDA product code for Kodiak Lumbar Spacer System is MAX.

其他以 Met One Technologies, LLC 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：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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官方來源

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