FDA 510(k)

IRIX-A 腰椎整合融合系統

K 號：K171567 · 2017-08-28

決定日期2017-08-28

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

IRIX-A Lumbar Integrated Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K171567. 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 IRIX-A Lumbar Integrated Fusion System?

IRIX-A Lumbar Integrated Fusion System is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K171567.

When did IRIX-A Lumbar Integrated Fusion System receive FDA 510(k) clearance?

IRIX-A Lumbar Integrated Fusion System received FDA 510(k) clearance on 2017-08-28, under 510(k) number K171567.

Who is the listed applicant for IRIX-A Lumbar Integrated Fusion System?

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

What is the FDA product code for IRIX-A Lumbar Integrated Fusion System?

The FDA product code for IRIX-A Lumbar Integrated Fusion System is OVD.

其他以 X-Spine Systems, 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。

K173832InTice™-C 多孔 Ti 頸椎間板系統 K180153X脊椎皮質骨釘系統 K170119凱利克斯腰椎脊椎植入系統 K171075凱利克斯-C 頸椎間置體 K170224蜘蛛脊椎板系統 K170530Butrex 腰椎支撐板系統

查看所有 11 項裝置 →

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。