FDA 510(k)

EPIC四肢快速斷開螺釘

K 號：K163038 · 2017-02-28

決定日期2017-02-28

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

EPIC Extremity Snap-Off Screw is the device name listed in this FDA 510(k) record. The listed applicant is Epic Extremity, LLC. It received FDA 510(k) clearance on 2017-02-28 under 510(k) number K163038. 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 EPIC Extremity Snap-Off Screw?

EPIC Extremity Snap-Off Screw is a medical device that received FDA 510(k) clearance on 2017-02-28. The listed applicant is Epic Extremity, LLC. The 510(k) number is K163038.

When did EPIC Extremity Snap-Off Screw receive FDA 510(k) clearance?

EPIC Extremity Snap-Off Screw received FDA 510(k) clearance on 2017-02-28, under 510(k) number K163038.

Who is the listed applicant for EPIC Extremity Snap-Off Screw?

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

What is the FDA product code for EPIC Extremity Snap-Off Screw?

The FDA product code for EPIC Extremity Snap-Off Screw is HWC. This falls under the Cardiovascular category.

其他以 Epic Extremity, LLC 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。

K182991EPIC四肢融合板系統 K172441EPIC四肢骨折板系統 K153340Epic extremity plate 系統 K153333Epic extremity 穿刺螺釘系統

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。