FDA 510(k)

伽馬4系統

K 號：K222309 · 2022-11-15

決定日期2022-11-15

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Gamma4 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 2022-11-15 under 510(k) number K222309. 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 Gamma4 System?

Gamma4 System is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Stryker GmbH. The 510(k) number is K222309.

When did Gamma4 System receive FDA 510(k) clearance?

Gamma4 System received FDA 510(k) clearance on 2022-11-15, under 510(k) number K222309.

Who is the listed applicant for Gamma4 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 Gamma4 System?

The FDA product code for Gamma4 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 K251400T2 遥臂螺釘系統；IMN 螺釘系統；T2 螺釘系統 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

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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.

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