FDA 510(k)

SCARLET® AC-Ti

K 號：K240699 · 2024-05-10

決定日期2024-05-10

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

SCARLET® AC-Ti is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240699. 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 SCARLET® AC-Ti?

SCARLET® AC-Ti is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Spineart SA. The 510(k) number is K240699.

When did SCARLET® AC-Ti receive FDA 510(k) clearance?

SCARLET® AC-Ti received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240699.

Who is the listed applicant for SCARLET® AC-Ti?

FDA 510(k) 記錄將 Spineart SA 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SCARLET® AC-Ti?

The FDA product code for SCARLET® AC-Ti is OVE.

其他以 Spineart SA 為申請人之記錄

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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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