FDA 510(k)

Z-Span 板系統

K 號：K162824 · 2017-02-17

決定日期2017-02-17

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Z-Span Plate 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 2017-02-17 under 510(k) number K162824. 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 Z-Span Plate System?

Z-Span Plate System is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Zavation, LLC. The 510(k) number is K162824.

When did Z-Span Plate System receive FDA 510(k) clearance?

Z-Span Plate System received FDA 510(k) clearance on 2017-02-17, under 510(k) number K162824.

Who is the listed applicant for Z-Span Plate 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 Z-Span Plate System?

The FDA product code for Z-Span Plate System is KWQ.

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 K161016Z-Clamp ISP系統 K153404Zavation脊椎系統 K160362Z-Span 板系統

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

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