FDA 510(k)

T2 遥臂螺釘系統；IMN 螺釘系統；T2 螺釘系統

K 號：K251400 · 2025-08-20

決定日期2025-08-20

產品代碼HSB

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器材摘要

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251400. 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 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System?

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Stryker GmbH. The 510(k) number is K251400.

When did T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System receive FDA 510(k) clearance?

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251400.

Who is the listed applicant for T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System?

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

What is the FDA product code for T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System?

The FDA product code for T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System is HSB.

其他以 Stryker 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。

K261481Pangea 髋骨重建系統 K253640T2 Alpha 髋骨後向釘固定系統；Pangea 髋骨重建系統 K253202霍夫曼LRF系統 K250163T2 Alpha Femur Retrograde Nailing System K242445Pangea 平台；Pangea 髋骨板系統；Pangea 臂骨板系統；Pangea 腓骨板系統 K233919VariAx 2 腕骨遠端系統

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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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