FDA 510(k)

Xenco醫療多層級頸椎套件

K 號：K213456 · 2021-12-21

決定日期2021-12-21

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Xenco Medical Multilevel CerviKit is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213456. 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 Xenco Medical Multilevel CerviKit?

Xenco Medical Multilevel CerviKit is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Xenco Medical, LLC. The 510(k) number is K213456.

When did Xenco Medical Multilevel CerviKit receive FDA 510(k) clearance?

Xenco Medical Multilevel CerviKit received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213456.

Who is the listed applicant for Xenco Medical Multilevel CerviKit?

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

What is the FDA product code for Xenco Medical Multilevel CerviKit?

The FDA product code for Xenco Medical Multilevel CerviKit is KWQ.

其他以 Xenco Medical, 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。

K243673Xenco Medical CancelleX 頸椎間板系統 K223059Xenco醫療 InterAlign 頸椎間板系統 K191074索倫托骨移植代用品 K190364取消勒X多孔钛腰椎間置入式設備 K173933索倫托生物玻璃骨移植代用品 K180373取消勒X多孔钛腰椎間置入式設備

查看所有 11 項裝置 →

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。