FDA 510(k)

美迪娜前頸椎板系統

K 號：K201521 · 2020-08-06

決定日期2020-08-06

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Medina Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Partners, LLC. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201521. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medina Anterior Cervical Plate System?

Medina Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Alliance Partners, LLC. The 510(k) number is K201521.

When did Medina Anterior Cervical Plate System receive FDA 510(k) clearance?

Medina Anterior Cervical Plate System received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201521.

Who is the listed applicant for Medina Anterior Cervical Plate System?

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

What is the FDA product code for Medina Anterior Cervical Plate System?

The FDA product code for Medina Anterior Cervical Plate System is KWQ.

其他以 Alliance Partners, 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。

K173128Alamo® C

相關器械（代碼：KWQ）

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。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLC K252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

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。