FDA 510(k)

DeGen醫療Latitude-C AM脊椎間融合系統

K 號：K252737 · 2025-10-10

決定日期2025-10-10

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

DeGen Medical Latitude-C AM Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K252737. 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 DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

DeGen Medical Latitude-C AM Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Degen Medical. The 510(k) number is K252737.

When did DeGen Medical Latitude-C AM Cervical Interbody Fusion System receive FDA 510(k) clearance?

DeGen Medical Latitude-C AM Cervical Interbody Fusion System received FDA 510(k) clearance on 2025-10-10, under 510(k) number K252737.

Who is the listed applicant for DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

The FDA 510(k) record lists Degen Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

The FDA product code for DeGen Medical Latitude-C AM Cervical Interbody Fusion System is ODP.

其他以 Degen Medical 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：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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