FDA 510(k)

史坦曼針及克irschner 銅絲

K 號：K211508 · 2021-10-05

決定日期2021-10-05

產品代碼JDW

諮詢委員會或

決定相當於

器材摘要

Steinmann Pins and Kirschner Wires is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K211508. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Steinmann Pins and Kirschner Wires?

Steinmann Pins and Kirschner Wires is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Stryker GmbH. The 510(k) number is K211508.

When did Steinmann Pins and Kirschner Wires receive FDA 510(k) clearance?

Steinmann Pins and Kirschner Wires received FDA 510(k) clearance on 2021-10-05, under 510(k) number K211508.

Who is the listed applicant for Steinmann Pins and Kirschner Wires?

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 Steinmann Pins and Kirschner Wires?

The FDA product code for Steinmann Pins and Kirschner Wires is JDW.

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

查看所有 53 項裝置 →

相關器械（代碼：JDW）

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。

K260073XT3 系統；XT3 系統，迷你型；XT3 系統，40mm；XT3 系統，迷你型，40mmBiodynamik, Inc.K250316中樞骨內髓骨折固定（IFF）系統Meduloc, LLC K241357XT3 系統Biodynamik, Inc.K223112MAVERICK迷你外固定系統Smith & Nephew, Inc.K213874MAVERICK 外固定系統Smith & Nephew, Inc.K210784延長型HA半針Smith & Nephew, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。