FDA 510(k)

DuoHex CH 穿刺針式槌狹腳趾系統

K 號：K200840 · 2020-06-26

決定日期2020-06-26

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

DuoHex CH Cannulated Hammertoe System is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200840. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the DuoHex CH Cannulated Hammertoe System?

DuoHex CH Cannulated Hammertoe System is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K200840.

When did DuoHex CH Cannulated Hammertoe System receive FDA 510(k) clearance?

DuoHex CH Cannulated Hammertoe System received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200840.

Who is the listed applicant for DuoHex CH Cannulated Hammertoe System?

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

What is the FDA product code for DuoHex CH Cannulated Hammertoe System?

The FDA product code for DuoHex CH Cannulated Hammertoe System is HWC. This falls under the Cardiovascular category.

其他以 Nextremity Solutions, 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。

K221610Nextra CH 穿刺針式槌狹趾系統 K212979CalcShift™ 足跟骨截骨術系統 K220181StealthFix 骨內固定系統 K213301InCore足弓系統 K213530Nextra CH 穿刺針式槌狹趾系統 K212640Stratum® 腳踝融合板系統

查看所有 14 項裝置 →

相關器械（代碼：HWC）

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。

K262975Arthrex Beaming系統Arthrex, Inc.K260995DynaNail螺旋®固定系統MedShape, Inc.K254280F.A.S.T. 螺釘Steps Ortho K261057ActivaScrew™ 穿刺式 COMBioretec, Ltd.K260106OsteoCoil™ GT 活動壓縮系統Flower Orthopedics Corporation DBA Conventus Flower Orthoped K262344大型壓縮螺釘TriMed, 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。