FDA 510(k)

維樂福™ TLIF 金屬內固定器

K 號：K172419 · 2017-12-04

決定日期2017-12-04

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Velofix™ TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2017-12-04 under 510(k) number K172419. 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 Velofix™ TLIF Cage?

Velofix™ TLIF Cage is a medical device that received FDA 510(k) clearance on 2017-12-04. The listed applicant is U&I Corporation. The 510(k) number is K172419.

When did Velofix™ TLIF Cage receive FDA 510(k) clearance?

Velofix™ TLIF Cage received FDA 510(k) clearance on 2017-12-04, under 510(k) number K172419.

Who is the listed applicant for Velofix™ TLIF Cage?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velofix™ TLIF Cage?

The FDA product code for Velofix™ TLIF Cage is MAX.

其他以 U&I Corporation 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。

K220147Aspiron S ACP 系統 K210573維洛菲克斯SA頸椎籠 K183243維洛菲克斯TLIF金屬支架 K190067維洛菲克斯內固定融合系統 K190053SECULOK™ ACP 系統 K181824CBT 螺釘固定系統

查看所有 16 項裝置 →

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。

K261049SCALA® TLSpineart SA K261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

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。