FDA 510(k)

Idys™ TLIF 3DTi 金屬板

K 號：K172465 · 2017-12-15

決定日期2017-12-15

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Idys™ TLIF 3DTi Cages is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172465. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Idys™ TLIF 3DTi Cages?

Idys™ TLIF 3DTi Cages is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Clariance, Sas. The 510(k) number is K172465.

When did Idys™ TLIF 3DTi Cages receive FDA 510(k) clearance?

Idys™ TLIF 3DTi Cages received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172465.

Who is the listed applicant for Idys™ TLIF 3DTi Cages?

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™ TLIF 3DTi Cages?

The FDA product code for Idys™ TLIF 3DTi Cages is MAX.

其他以 Clariance, Sas 為申請人之記錄

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相關器械（代碼：MAX）

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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