FDA 510(k)

TiWAVE-C™多孔钛颈椎籠

K 號：K180401 · 2018-06-14

決定日期2018-06-14

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

TiWAVE-C™ Porous Titanium Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K180401. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TiWAVE-C™ Porous Titanium Cervical Cage?

TiWAVE-C™ Porous Titanium Cervical Cage is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Kalitec Direct, LLC. The 510(k) number is K180401.

When did TiWAVE-C™ Porous Titanium Cervical Cage receive FDA 510(k) clearance?

TiWAVE-C™ Porous Titanium Cervical Cage received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180401.

Who is the listed applicant for TiWAVE-C™ Porous Titanium Cervical Cage?

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

What is the FDA product code for TiWAVE-C™ Porous Titanium Cervical Cage?

The FDA product code for TiWAVE-C™ Porous Titanium Cervical Cage is ODP.

其他以 Kalitec Direct, LLC 為申請人之記錄

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相關器械（代碼：ODP）

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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