FDA 510(k)

Zavation脊椎系統

K 號：K153404 · 2016-04-21

決定日期2016-04-21

產品代碼MNH

諮詢委員會或

決定相當於

器材摘要

Zavation Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation, LLC. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K153404. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Zavation Spinal System?

Zavation Spinal System is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Zavation, LLC. The 510(k) number is K153404.

When did Zavation Spinal System receive FDA 510(k) clearance?

Zavation Spinal System received FDA 510(k) clearance on 2016-04-21, under 510(k) number K153404.

Who is the listed applicant for Zavation Spinal System?

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

What is the FDA product code for Zavation Spinal System?

The FDA product code for Zavation Spinal System is MNH. This falls under the ENT category.

其他以 Zavation, 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。

K162206Zavation IBF K162575Z-LINKPC 系統 K162824Z-Span 板系統 K161016Z-Clamp ISP系統 K160362Z-Span 板系統

相關器械（代碼：MNH）

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。

K162066依賴脊椎螺釘系統Reliance Medical Systems, LLC K162801CastleLoc脊椎固定系統L&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151脊椎固定系統Canwell Medical Co., Ltd.K162189ANAX™ 5.5 脊柱系統U&I Corporation K151362HC脊椎系統Hung Chun Bio-S Co., Ltd.

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。