FDA 510(k)

Arthrex DynaNite Nitinol Staples

K 號：K243742 · 2025-01-31

決定日期2025-01-31

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

Arthrex DynaNite Nitinol Staples is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K243742. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arthrex DynaNite Nitinol Staples?

Arthrex DynaNite Nitinol Staples is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Arthrex, Inc.. The 510(k) number is K243742.

When did Arthrex DynaNite Nitinol Staples receive FDA 510(k) clearance?

Arthrex DynaNite Nitinol Staples received FDA 510(k) clearance on 2025-01-31, under 510(k) number K243742.

Who is the listed applicant for Arthrex DynaNite Nitinol Staples?

FDA 510(k) 記錄將 Arthrex, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Arthrex DynaNite Nitinol Staples?

The FDA product code for Arthrex DynaNite Nitinol Staples is JDR.

其他以 Arthrex, Inc. 為申請人之記錄

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相關器械（代碼：JDR）

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。

K262451Arthrex DynaNite 针Arthrex, Inc.K261121巨牙動態壓縮系統Paragon 28, Inc.K250712連結壓縮釘針系統Trax Surgical K243888Medline UNITE® REFLEX® 混合不銹鋼植入系統Medline Industries, LP K243658TMC壓力植入系統Treace Medical Concepts K242415TMC壓力植入系統Treace Medical Concepts

官方來源

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