FDA 510(k)

DynaClip® 骨釘

K 號：K220812 · 2022-08-19

決定日期2022-08-19

產品代碼JDR

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決定相當於

器材摘要

DynaClip® Bone Staple is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220812. 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 DynaClip® Bone Staple?

DynaClip® Bone Staple is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is MedShape, Inc.. The 510(k) number is K220812.

When did DynaClip® Bone Staple receive FDA 510(k) clearance?

DynaClip® Bone Staple received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220812.

Who is the listed applicant for DynaClip® Bone Staple?

FDA 510(k) 記錄將 MedShape, 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 DynaClip® Bone Staple?

The FDA product code for DynaClip® Bone Staple is JDR.

其他以 MedShape, Inc. 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。

K260995DynaNail螺旋®固定系統 K254110DynaNail Mini；DynaNail Hybrid；DynaNail Helix；DynaClip；DynaClip Forte；DynaClip Delta；DynaClip Quattro K250628DynaNail TTC 融合系統 K240530DynaNail Mini 縮窄混合型 K203595DynaFuse 固定系統 K203381迪納奈爾迷你混合式醫療設備

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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

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