FDA 510(k)

InSet 全肩關節系統

K 號：K241817 · 2025-02-11

決定日期2025-02-11

產品代碼KWT

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器材摘要

InSet Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K241817. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InSet Total Shoulder System?

InSet Total Shoulder System is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K241817.

When did InSet Total Shoulder System receive FDA 510(k) clearance?

InSet Total Shoulder System received FDA 510(k) clearance on 2025-02-11, under 510(k) number K241817.

Who is the listed applicant for InSet Total Shoulder System?

FDA 510(k) 記錄將 Shoulder Innovations, 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 InSet Total Shoulder System?

The FDA product code for InSet Total Shoulder System is KWT.

其他以 Shoulder Innovations, 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。

K262173N22 選擇性肱骨頭 K254128InSet逆向全肩關節系統 K252516N22 輕量球體 K252221內置逆向全肩關節系統 K213615肩部創新全肩系統 K210533內置逆向全肩關節系統

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相關器械（代碼：KWT）

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。

K262173N22 選擇性肱骨頭Shoulder Innovations, Inc.K250713Equinoxe® 肱骨重建義肢；Equinoxe® 無柄肩關節植入體Exactech, Inc.K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO肩部置換系統Implantcast GmbH K231657AGILON® XO肩部置換系統Implantcast GmbH K223631全面斷層修復系統(SRS)Biomet Orthopedics

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