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FDA 510(k)

KYPHON HV-R 穿孔螺釘水泥，CD HORIZON 穿孔螺釘組

K 號：K152604 · 2016-01-06

申請人Medtronic Sofamor Danek USA, Incorporated
決定日期2016-01-06
產品代碼PML
諮詢委員會或
決定相當於

器材摘要

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Incorporated. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K152604. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Medtronic Sofamor Danek USA, Incorporated. The 510(k) number is K152604.

When did KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set receive FDA 510(k) clearance?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2016-01-06, under 510(k) number K152604.

Who is the listed applicant for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is PML.

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

相關器械（代碼：PML）

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。

K260286Dynamo™脊椎水泥；Salvo®脊椎系統Spine Wave, Inc.K252885奧林匹克後脊椎固定系統；馬薩達模組化脊椎固定系統Astura MedicalK241034Meta+ 骨水泥 & M.U.S.T. 穿孔椎板螺釘系統Medacta International S.A.K231809Momentum® 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥；Momentum® MIS 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥Ulrich Medical USAK230774PERLA® TL 系統；TEKTONA® HV US 骨水泥SpineartK222789VADER®脊椎系統，G21水泥Icotec AG

官方來源

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