FDA 510(k)

Idys® C ZP 3DTi

K 號：K240715 · 2024-03-22

決定日期2024-03-22

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Idys® C ZP 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K240715. 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 Idys® C ZP 3DTi?

Idys® C ZP 3DTi is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Clariance. The 510(k) number is K240715.

When did Idys® C ZP 3DTi receive FDA 510(k) clearance?

Idys® C ZP 3DTi received FDA 510(k) clearance on 2024-03-22, under 510(k) number K240715.

Who is the listed applicant for Idys® C ZP 3DTi?

The FDA 510(k) record lists Clariance as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Idys® C ZP 3DTi?

The FDA product code for Idys® C ZP 3DTi is OVE.

其他以 Clariance 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。

K243904Elegance® 前頸板 K243670Idys® LIF K241863Erisma® Lp脊椎固定系統；Erisma® LP MIS K240872Erisma® 叭曲脊椎系統；Erisma® Lp 脊椎固定系統 K220182Aggeris™-C K200919Idys ALIF 3DTi

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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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