FDA 510(k)

APTUS Shoulder Proximal Humerus System, PentaLock 3.5

K 號：K253916 · 2026-03-16

決定日期2026-03-16

產品代碼HRS

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器材摘要

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253916. 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 Shoulder Proximal Humerus System, PentaLock 3.5?

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Medartis AG. The 510(k) number is K253916.

When did APTUS Shoulder Proximal Humerus System, PentaLock 3.5 receive FDA 510(k) clearance?

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253916.

Who is the listed applicant for APTUS Shoulder Proximal Humerus System, PentaLock 3.5?

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 Shoulder Proximal Humerus System, PentaLock 3.5?

The FDA product code for APTUS Shoulder Proximal Humerus System, PentaLock 3.5 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。

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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。

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