FDA 510(k)

TiWAVE-L多孔钛腰椎籠

K 號：K182210 · 2019-01-07

決定日期2019-01-07

產品代碼MAX

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決定相當於

器材摘要

TiWAVE-L Porous Titanium Lumbar Cage is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Medical, LLC. It received FDA 510(k) clearance on 2019-01-07 under 510(k) number K182210. 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 TiWAVE-L Porous Titanium Lumbar Cage?

TiWAVE-L Porous Titanium Lumbar Cage is a medical device that received FDA 510(k) clearance on 2019-01-07. The listed applicant is Kalitec Medical, LLC. The 510(k) number is K182210.

When did TiWAVE-L Porous Titanium Lumbar Cage receive FDA 510(k) clearance?

TiWAVE-L Porous Titanium Lumbar Cage received FDA 510(k) clearance on 2019-01-07, under 510(k) number K182210.

Who is the listed applicant for TiWAVE-L Porous Titanium Lumbar Cage?

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

What is the FDA product code for TiWAVE-L Porous Titanium Lumbar Cage?

The FDA product code for TiWAVE-L Porous Titanium Lumbar Cage is MAX.

其他以 Kalitec Medical, LLC 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。

K220902導航腰椎籠

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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