FDA 510(k)

Affixus® 自然釘® 近端上臂系統

K 號：K253749 · 2025-12-12

申請人Zimmer Switzerland Manufacturing GmbH

決定日期2025-12-12

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Affixus® Natural Nail® Proximal Humeral System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K253749. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Affixus® Natural Nail® Proximal Humeral System?

Affixus® Natural Nail® Proximal Humeral System is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K253749.

When did Affixus® Natural Nail® Proximal Humeral System receive FDA 510(k) clearance?

Affixus® Natural Nail® Proximal Humeral System received FDA 510(k) clearance on 2025-12-12, under 510(k) number K253749.

Who is the listed applicant for Affixus® Natural Nail® Proximal Humeral System?

The FDA 510(k) record lists Zimmer Switzerland Manufacturing GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Affixus® Natural Nail® Proximal Humeral System?

The FDA product code for Affixus® Natural Nail® Proximal Humeral System is HSB.

其他以 Zimmer Switzerland Manufacturing GmbH 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。

K241754NCB®多軸固定板系統；NCB®人工關節股骨板系統；NCB®電纜按鈕；NCB®直窄軸板 K231114Zimmer® 自然指甲® 系統頭骨脊髓釘；Affixus® 自然指甲® 肱骨釘系統 K212129Persona® 預設膝關節系統

相關器械（代碼：HSB）

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。

K261345兒童釘針平台髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbH K253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized Orthopedics K253155富麗金屬可鎖定內骨髓釘系統Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.

官方來源

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