FDA 510(k)

MectaLIF 前置獨立支架

K 號：K160605 · 2016-07-21

決定日期2016-07-21

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

MectaLIF Anterior Stand-Alone is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K160605. 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 MectaLIF Anterior Stand-Alone?

MectaLIF Anterior Stand-Alone is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Medacta International. The 510(k) number is K160605.

When did MectaLIF Anterior Stand-Alone receive FDA 510(k) clearance?

MectaLIF Anterior Stand-Alone received FDA 510(k) clearance on 2016-07-21, under 510(k) number K160605.

Who is the listed applicant for MectaLIF Anterior Stand-Alone?

The FDA 510(k) record lists Medacta International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MectaLIF Anterior Stand-Alone?

The FDA product code for MectaLIF Anterior Stand-Alone is OVD.

其他以 Medacta International 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。

K160289MasterLoc 腳跟處理器 K153664M.U.S.T. 椎骨螺釘系統

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA Innovasis K261408SABER-XA 系統Elevation Spine K261809Interwedge® 独立側邊架Foundation Surgical Group K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLC K254202MectaLIF 3D金屬前臍Medacta International S.A.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。