FDA 510(k)

蜘蛛脊椎板系統

K 號：K170224 · 2017-07-06

決定日期2017-07-06

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Spider Cervical Plating System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K170224. 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 Spider Cervical Plating System?

Spider Cervical Plating System is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K170224.

When did Spider Cervical Plating System receive FDA 510(k) clearance?

Spider Cervical Plating System received FDA 510(k) clearance on 2017-07-06, under 510(k) number K170224.

Who is the listed applicant for Spider Cervical Plating System?

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

What is the FDA product code for Spider Cervical Plating System?

The FDA product code for Spider Cervical Plating System is KWQ.

其他以 X-Spine Systems, Inc. 為申請人之記錄

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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

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