FDA 510(k)

Tryptik Ti

K 號：K230583 · 2023-03-22

決定日期2023-03-22

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Tryptik 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 2023-03-22 under 510(k) number K230583. 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 Tryptik Ti?

Tryptik Ti is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Spineart SA. The 510(k) number is K230583.

When did Tryptik Ti receive FDA 510(k) clearance?

Tryptik Ti received FDA 510(k) clearance on 2023-03-22, under 510(k) number K230583.

Who is the listed applicant for Tryptik 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 Tryptik Ti?

The FDA product code for Tryptik Ti is ODP.

其他以 Spineart SA 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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官方來源

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