FDA 510(k)

SPICCA脊椎融合籠

K 號：K230607 · 2023-08-14

決定日期2023-08-14

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

SPICCA 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 K230607. 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 SPICCA Cervical Fusion Cages?

SPICCA 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 K230607.

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

SPICCA Cervical Fusion Cages received FDA 510(k) clearance on 2023-08-14, under 510(k) number K230607.

Who is the listed applicant for SPICCA 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 Cervical Fusion Cages?

The FDA product code for SPICCA Cervical Fusion Cages is ODP.

其他以 Southern Medical (Pty) , Ltd. 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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