FDA 510(k)

IVA籠架Ti（ACIF、PLIF、TLIF、DLIF及ALIF）

K 號：K173080 · 2017-10-31

決定日期2017-10-31

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K173080. 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 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)?

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K173080.

When did IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) receive FDA 510(k) clearance?

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) received FDA 510(k) clearance on 2017-10-31, under 510(k) number K173080.

Who is the listed applicant for IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)?

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

What is the FDA product code for IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)?

The FDA product code for IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is MAX.

其他以 Huvexel Co. , Ltd. 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。

K213820BALTEUM - ONE™ 椎板系統 K200846Balteum™ 腰椎板系統 K191477AEON-C 独立系統 K180729法塞固定系統 K173201UNITY 骨盆釘合系統 K173131Rexious脊椎固定系統

查看所有 8 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。