FDA 510(k)

AXTi 钛合金獨立 ALIF 系統

K 號：K182139 · 2019-06-21

決定日期2019-06-21

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

AXTi Titanium Stand-Alone ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K182139. 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 AXTi Titanium Stand-Alone ALIF System?

AXTi Titanium Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Innovasis, Inc.. The 510(k) number is K182139.

When did AXTi Titanium Stand-Alone ALIF System receive FDA 510(k) clearance?

AXTi Titanium Stand-Alone ALIF System received FDA 510(k) clearance on 2019-06-21, under 510(k) number K182139.

Who is the listed applicant for AXTi Titanium Stand-Alone ALIF System?

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

What is the FDA product code for AXTi Titanium Stand-Alone ALIF System?

The FDA product code for AXTi Titanium Stand-Alone ALIF System is OVD.

其他以 Innovasis, 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。

K251073Innovasis導航儀器（Vector G-E導航儀器和Excella G-E導航儀器）K250182Innovasis導航儀器 K241276Vector™脊椎螺釘系統 K231899HAtetracell™-C 鈦金屬頸椎內固定系統 K223511精確導航儀器 K223510Matrix HA融合多孔頸椎IBF系統

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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。

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

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