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FDA 510(k)

Peekplus® 間體融合設備

K 號：K173864 · 2018-07-02

申請人Vallum Corporation
決定日期2018-07-02
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

Peekplus® Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Vallum Corporation. It received FDA 510(k) clearance on 2018-07-02 under 510(k) number K173864. 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 Peekplus® Interbody Fusion Device?

Peekplus® Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-07-02. The listed applicant is Vallum Corporation. The 510(k) number is K173864.

When did Peekplus® Interbody Fusion Device receive FDA 510(k) clearance?

Peekplus® Interbody Fusion Device received FDA 510(k) clearance on 2018-07-02, under 510(k) number K173864.

Who is the listed applicant for Peekplus® Interbody Fusion Device?

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

What is the FDA product code for Peekplus® Interbody Fusion Device?

The FDA product code for Peekplus® Interbody Fusion Device is MAX.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 SAK261430TruLift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 CorporationK253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

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