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FDA 510(k)

Flex-Thread™ 達骨內髓釘系統

K 號：K222390 · 2022-11-21

申請人Flower Orthopedics Corporation Dba Conventus Flower
決定日期2022-11-21
產品代碼HSB
諮詢委員會或
決定相當於

器材摘要

Flex-Thread™ Ulna Intramedullary Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222390. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flex-Thread™ Ulna Intramedullary Nail System?

Flex-Thread™ Ulna Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower. The 510(k) number is K222390.

When did Flex-Thread™ Ulna Intramedullary Nail System receive FDA 510(k) clearance?

Flex-Thread™ Ulna Intramedullary Nail System received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222390.

Who is the listed applicant for Flex-Thread™ Ulna Intramedullary Nail System?

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

What is the FDA product code for Flex-Thread™ Ulna Intramedullary Nail System?

The FDA product code for Flex-Thread™ Ulna Intramedullary Nail System is HSB.

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 Flower Orthopedics Corporation Dba Conventus Flower 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。

K212030Flex-Thread™ 遠端腓骨內髓釘系統

相關器械（代碼：HSB）

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。

K261345兒童釘針平台 髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbHK253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized OrthopedicsK253155富麗金屬可鎖定內骨髓釘系統Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.

官方來源

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