FDA 510(k)

Idys LLIF 3DTi

K 號：K202032 · 2021-04-01

決定日期2021-04-01

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Idys LLIF 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K202032. 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 Idys LLIF 3DTi?

Idys LLIF 3DTi is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Clariance, Sas. The 510(k) number is K202032.

When did Idys LLIF 3DTi receive FDA 510(k) clearance?

Idys LLIF 3DTi received FDA 510(k) clearance on 2021-04-01, under 510(k) number K202032.

Who is the listed applicant for Idys LLIF 3DTi?

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

What is the FDA product code for Idys LLIF 3DTi?

The FDA product code for Idys LLIF 3DTi is OVD.

其他以 Clariance, Sas 為申請人之記錄

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K202956Erisma LP 精準導航儀器 K200920Idys ALIF ZP 3DTi 医療設備規範文本 K192168Idys ALIF ZP 3DTi 医療設備規範文本 K191263Idys ALIF TiVac K183259Idys™ TLIF TiVac K172465Idys™ TLIF 3DTi 金屬板

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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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