FDA 510(k)

extremity 鋼釘

K 號：K231458 · 2023-08-03

決定日期2023-08-03

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

Extremity Staple is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K231458. 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 Extremity Staple?

Extremity Staple is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Restor3D. The 510(k) number is K231458.

When did Extremity Staple receive FDA 510(k) clearance?

Extremity Staple received FDA 510(k) clearance on 2023-08-03, under 510(k) number K231458.

Who is the listed applicant for Extremity Staple?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extremity Staple?

The FDA product code for Extremity Staple is JDR.

其他以 Restor3D 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。

K260556Veritas肩部系統 K253992Veritas逆向全肩關節系統 K252454金諾斯全腳踝系統 K243643restor3d 過全肩關節置换系統 K242868金諾斯全腳踝系統 K241482金諾斯全腳踝系統

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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 K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC壓力植入系統Treace Medical Concepts

官方來源

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