FDA 510(k)

Avenue® T TLIF 籠

K 號：K161173 · 2016-09-28

決定日期2016-09-28

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Avenue® T TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161173. 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 Avenue® T TLIF Cage?

Avenue® T TLIF Cage is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K161173.

When did Avenue® T TLIF Cage receive FDA 510(k) clearance?

Avenue® T TLIF Cage received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161173.

Who is the listed applicant for Avenue® T TLIF Cage?

The FDA 510(k) record lists Ldr Spine USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avenue® T TLIF Cage?

The FDA product code for Avenue® T TLIF Cage is OVD.

其他以 Ldr Spine USA, Inc. 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：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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