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FDA 510(k)

Camber Spine Technologies SPIRA - V™ 開放矩陣椎體切除籠

K 號：K173800 · 2018-02-02

申請人Camber Spine Technologies
決定日期2018-02-02
產品代碼MQP
諮詢委員會或
決定相當於

器材摘要

Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K173800. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage?

Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Camber Spine Technologies. The 510(k) number is K173800.

When did Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage receive FDA 510(k) clearance?

Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage received FDA 510(k) clearance on 2018-02-02, under 510(k) number K173800.

Who is the listed applicant for Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage?

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

What is the FDA product code for Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage?

The FDA product code for Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage is MQP.

相關臨床試驗

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。

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

其他以 Camber Spine Technologies 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。

K234077SPIRA® 前腰椎間隔器K233972Camber 骨盆釘定系統K230942SPIRA® 腰椎後部間隔器K221324ENZA-O 鈦金屬側前方腰椎間融合術（ALIF）K223837SPIRA®-C 整合固定系統K220038Camber脊椎導航系統

查看所有 16 項裝置 →

相關器械（代碼：MQP）

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。

K261810維蒂威奇® 骨內系統Foundation Surgical GroupK261031波塞冬STSignus Medinzintechnik GmbHK253158VyBrate™ VBR 系統Vy Spine, LLCK241468維蒂威奇® 骨內系統Foundation Surgical Group, Inc.K232790KONG®-TL VBR 系統及 KONG® C VBR 系統Icotec AGK233359DOMINION可擴展椎體切除系統Astura Medical

官方來源

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