FDA 510(k)

SPICCA 独立式脊椎融合籠

K 號：K230608 · 2023-08-14

決定日期2023-08-14

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

SPICCA Stand-Alone Cervical Fusion Cages is the device name listed in this FDA 510(k) record. The listed applicant is Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-08-14 under 510(k) number K230608. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPICCA Stand-Alone Cervical Fusion Cages?

SPICCA Stand-Alone Cervical Fusion Cages is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K230608.

When did SPICCA Stand-Alone Cervical Fusion Cages receive FDA 510(k) clearance?

SPICCA Stand-Alone Cervical Fusion Cages received FDA 510(k) clearance on 2023-08-14, under 510(k) number K230608.

Who is the listed applicant for SPICCA Stand-Alone Cervical Fusion Cages?

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

What is the FDA product code for SPICCA Stand-Alone Cervical Fusion Cages?

The FDA product code for SPICCA Stand-Alone Cervical Fusion Cages is OVE.

其他以 Southern Medical (Pty) , Ltd. 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：OVE）

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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