FDA 510(k)

史密斯與內夫ACCORD™ 線路系統

K 號：K223762 · 2023-05-30

決定日期2023-05-30

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Smith & Nephew ACCORD™ Cable System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K223762. 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 Smith & Nephew ACCORD™ Cable System?

Smith & Nephew ACCORD™ Cable System is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Smith & Nephew. The 510(k) number is K223762.

When did Smith & Nephew ACCORD™ Cable System receive FDA 510(k) clearance?

Smith & Nephew ACCORD™ Cable System received FDA 510(k) clearance on 2023-05-30, under 510(k) number K223762.

Who is the listed applicant for Smith & Nephew ACCORD™ Cable System?

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

What is the FDA product code for Smith & Nephew ACCORD™ Cable System?

The FDA product code for Smith & Nephew ACCORD™ Cable System is HRS.

其他以 Smith & Nephew 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。

K241666EVOS 骨盆及骨盂系統 K240487EVOS 閃光板 K233730Footprint Mini PK, 3.5mm 緝合釘 K232457Q-FIX ULTRA 全縫線固定釘 K203566藥丸應用程序 K201253模組化軌道系統，TAYLOR 空間架外固定器，JET-X 外固定器，伊利扎羅夫外固定器，其他外固定器

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 Technologies K262963TMC 偽骨固定系統Treace Medical Concepts, Inc.K261647Tempo植板系統；超壓縮螺釘系統Pace Surgical K261830FRAXION 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 Sirketi K262537Versalock 無菌板片系統GM Dos Reis Industria e Comercio Ltda.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。