FDA 510(k)

Juliet® Ti LL 腰椎間盤設備

K 號：K241321 · 2024-07-18

決定日期2024-07-18

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Juliet® Ti LL Lumbar Interbody Device is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K241321. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Juliet® Ti LL Lumbar Interbody Device?

Juliet® Ti LL Lumbar Interbody Device is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Spineart SA. The 510(k) number is K241321.

When did Juliet® Ti LL Lumbar Interbody Device receive FDA 510(k) clearance?

Juliet® Ti LL Lumbar Interbody Device received FDA 510(k) clearance on 2024-07-18, under 510(k) number K241321.

Who is the listed applicant for Juliet® Ti LL Lumbar Interbody Device?

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 Juliet® Ti LL Lumbar Interbody Device?

The FDA product code for Juliet® Ti LL Lumbar Interbody Device is OVD.

其他以 Spineart SA 為申請人之記錄

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相關器械（代碼：OVD）

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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