FDA 510(k)

HammerTech 固定系統

K 號：K161449 · 2016-10-11

決定日期2016-10-11

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

HammerTech Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2016-10-11 under 510(k) number K161449. 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 HammerTech Fixation System?

HammerTech Fixation System is a medical device that received FDA 510(k) clearance on 2016-10-11. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K161449.

When did HammerTech Fixation System receive FDA 510(k) clearance?

HammerTech Fixation System received FDA 510(k) clearance on 2016-10-11, under 510(k) number K161449.

Who is the listed applicant for HammerTech Fixation System?

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

What is the FDA product code for HammerTech Fixation System?

The FDA product code for HammerTech Fixation System is HWC. This falls under the Cardiovascular category.

其他以 Fusion Orthopedics, 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。

K210159內鎖系統 K193377TopLock 牽引系統 K202959PolyLock 鍊接系統 K192323PolyLock 小骨板系統 K190136Fusion Silastic 系統 K182342IntraLock Lapidus 系統

查看所有 11 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。