FDA 510(k)

EIT細胞鈦金屬® 腰椎籠 LLIF

K 號：K181644 · 2018-10-12

申請人Eit Emerging Implant Technologies GmbH

決定日期2018-10-12

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

EIT Cellular Titanium® Lumbar Cage LLIF is the device name listed in this FDA 510(k) record. The listed applicant is Eit Emerging Implant Technologies GmbH. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181644. 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 EIT Cellular Titanium® Lumbar Cage LLIF?

EIT Cellular Titanium® Lumbar Cage LLIF is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Eit Emerging Implant Technologies GmbH. The 510(k) number is K181644.

When did EIT Cellular Titanium® Lumbar Cage LLIF receive FDA 510(k) clearance?

EIT Cellular Titanium® Lumbar Cage LLIF received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181644.

Who is the listed applicant for EIT Cellular Titanium® Lumbar Cage LLIF?

The FDA 510(k) record lists Eit Emerging Implant Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EIT Cellular Titanium® Lumbar Cage LLIF?

The FDA product code for EIT Cellular Titanium® Lumbar Cage LLIF is MAX.

其他以 Eit Emerging Implant Technologies GmbH 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。

K201605EIT細胞鋼钛頸椎金屬支架，EIT細胞鋼钛ALIF金屬支架，EIT細胞鋼钛TLIF金屬支架，EIT細胞鋼钛LLIF金屬支架，EIT細胞鋼钛T/PLIF金屬支架 K183447EIT 鋰金屬腰椎籠 - T/PLIF K172888EIT細胞鈦金屬®頸椎籠，EIT細胞鈦金屬®PLIF籠，EIT細胞鈦金屬®TLIF籠，EIT細胞鈦金屬®ALIF籠 K170503EIT細胞鋼钛頸椎金屬支架、EIT細胞鋼钛PLIF金屬支架、EIT細胞鋼钛TLIF金屬支架以及EIT細胞鋼钛ALIF金屬支架

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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