FDA 510(k)

科迪亞克C脊椎植入系統

K 號：K222806 · 2022-12-22

決定日期2022-12-22

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Kodiak C Spinal Implant 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 2022-12-22 under 510(k) number K222806. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kodiak C Spinal Implant System?

Kodiak C Spinal Implant System is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Met One Technologies, LLC. The 510(k) number is K222806.

When did Kodiak C Spinal Implant System receive FDA 510(k) clearance?

Kodiak C Spinal Implant System received FDA 510(k) clearance on 2022-12-22, under 510(k) number K222806.

Who is the listed applicant for Kodiak C Spinal Implant 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 C Spinal Implant System?

The FDA product code for Kodiak C Spinal Implant System is ODP.

其他以 Met One Technologies, LLC 為申請人之記錄

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相關器械（代碼：ODP）

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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