FDA 510(k)

SurgTech 選創系統

K 號：K161894 · 2017-02-21

決定日期2017-02-21

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

SurgTech Trauma System is the device name listed in this FDA 510(k) record. The listed applicant is Surgtech, Inc.. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K161894. 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 SurgTech Trauma System?

SurgTech Trauma System is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Surgtech, Inc.. The 510(k) number is K161894.

When did SurgTech Trauma System receive FDA 510(k) clearance?

SurgTech Trauma System received FDA 510(k) clearance on 2017-02-21, under 510(k) number K161894.

Who is the listed applicant for SurgTech Trauma System?

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

What is the FDA product code for SurgTech Trauma System?

The FDA product code for SurgTech Trauma System is HWC. This falls under the Cardiovascular category.

其他以 Surgtech, 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。

K191192SurgTech GENOLL 全膝系統 K173455SurgTech雙極頭系統 K162125馬魯克™ 全髋關節置换系統 K163363SurgTech 胸腰盆後固定系統 (TLS)K152200SurgTech 間體系統

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。

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