FDA 510(k)

DynaClip 骨釘

K 號：K193305 · 2020-04-23

決定日期2020-04-23

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 2020-04-23 under 510(k) number K193305. 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 2020-04-23. The listed applicant is MedShape, Inc.. The 510(k) number is K193305.

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

DynaClip Bone Staple received FDA 510(k) clearance on 2020-04-23, under 510(k) number K193305.

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 K220812DynaClip® 骨釘 K203595DynaFuse 固定系統

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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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