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FDA 510(k)

Treace醫療系統（TMC）植板系統

K 號：K240173 · 2024-02-22

申請人Treace Medical Concepts, Inc.
決定日期2024-02-22
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

Treace Medical Systems (TMC) Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K240173. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Treace Medical Systems (TMC) Plating System?

Treace Medical Systems (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K240173.

When did Treace Medical Systems (TMC) Plating System receive FDA 510(k) clearance?

Treace Medical Systems (TMC) Plating System received FDA 510(k) clearance on 2024-02-22, under 510(k) number K240173.

Who is the listed applicant for Treace Medical Systems (TMC) Plating System?

FDA 510(k) 記錄將 Treace Medical Concepts, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Treace Medical Systems (TMC) Plating System?

The FDA product code for Treace Medical Systems (TMC) Plating System is HRS.

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 Treace Medical Concepts, Inc. 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。

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查看所有 15 項裝置 →

相關器械（代碼：HRS）

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。

K261892ProRib固定系統Costa Surgical, Inc.K262098EnHAnce PEEK 趾骨隆起系統Nvision Biomedical TechnologiesK262963TMC 偽骨固定系統Treace Medical Concepts, Inc.K261647Tempo植板系統；超壓縮螺釘系統Pace SurgicalK261830FRAXION 3.5 板系統（多種 - 見目錄）；FRAXION 4.5 板系統（多種 - 見目錄）；FRAXION Mini 板系統（多種 - 見目錄）；FRAXION 骨釘系統（多種 - 見目錄）Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock 無菌板片系統GM Dos Reis Industria e Comercio Ltda.

官方來源

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