FDA 510(k)

APTUS 手部系統; APTUS 肘部背側桡骨頭板

K 號：K243610 · 2025-03-07

決定日期2025-03-07

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

APTUS Hand System; APTUS Elbow Dorsal Olecranon is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243610. 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 APTUS Hand System; APTUS Elbow Dorsal Olecranon?

APTUS Hand System; APTUS Elbow Dorsal Olecranon is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Medartis AG. The 510(k) number is K243610.

When did APTUS Hand System; APTUS Elbow Dorsal Olecranon receive FDA 510(k) clearance?

APTUS Hand System; APTUS Elbow Dorsal Olecranon received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243610.

Who is the listed applicant for APTUS Hand System; APTUS Elbow Dorsal Olecranon?

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

What is the FDA product code for APTUS Hand System; APTUS Elbow Dorsal Olecranon?

The FDA product code for APTUS Hand System; APTUS Elbow Dorsal Olecranon is HRS.

其他以 Medartis AG 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。

K260761APTUS 肩胛骨系統 2.8 K260934TITAN指甲針；APTUS K針系統 K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5 K240613APTUS 肘部背側桡骨頭板 K232105APTUS 足部系統 2.8-3.5 K234062APTUS 手部舟狀骨板

查看所有 23 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。