FDA 510(k)

Choice脊椎板成形術™固定系統

K 號：K173215 · 2018-01-19

決定日期2018-01-19

產品代碼NQW

諮詢委員會或

決定相當於

器材摘要

Choice Spine Laminoplasty™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173215. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Choice Spine Laminoplasty™ Fixation System?

Choice Spine Laminoplasty™ Fixation System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Choicespine, LP. The 510(k) number is K173215.

When did Choice Spine Laminoplasty™ Fixation System receive FDA 510(k) clearance?

Choice Spine Laminoplasty™ Fixation System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173215.

Who is the listed applicant for Choice Spine Laminoplasty™ Fixation System?

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

What is the FDA product code for Choice Spine Laminoplasty™ Fixation System?

The FDA product code for Choice Spine Laminoplasty™ Fixation System is NQW.

其他以 Choicespine, LP 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。

K190227Boomerang™ 頸椎前方板系統 K183397ChoiceSpine 隱形頸椎間隔系統 K182721選擇脊椎導航系統 K183214Raven脊椎板系統 K180519HARRIER-SA™ 腰椎間盤系統 K172816TiGer Shark™ 系統

查看所有 14 項裝置 →

相關器械（代碼：NQW）

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。

K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.K243137Curiteva多孔PEEK椎板成形系統Curiteva, Inc.K242784維斯賓™ 維拉姆™ 樂氏成形系統Vy Spine, LLC K232471維斯賓™ 維拉姆™ 樂氏成形系統Vy Spine, LLC K231232Curiteva 樂林術系統Curiteva, Inc.K212428中心板固定系統Medtronic Sofamor Danek

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。