FDA 510(k)

Choice Spine 鳳眼椎體置換系統 (VBR)

K 號：K183588 · 2019-02-22

決定日期2019-02-22

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K183588. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Choice Spine Hawkeye Vertebral Body Replacement (VBR) System?

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Choicespine. The 510(k) number is K183588.

When did Choice Spine Hawkeye Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183588.

Who is the listed applicant for Choice Spine Hawkeye Vertebral Body Replacement (VBR) System?

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

What is the FDA product code for Choice Spine Hawkeye Vertebral Body Replacement (VBR) System?

The FDA product code for Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is MQP.

其他以 Choicespine 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。

K171686Choice Spine Hawkeye™脊椎體置換系統 (VBR)K171456Thunderbolt™ 低侵入性與Lancer™ 開放椎板螺釘系統

相關器械（代碼：MQP）

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。

K261810維蒂威奇® 骨內系統Foundation Surgical Group K261031波塞冬STSignus Medinzintechnik GmbH K253158VyBrate™ VBR 系統Vy Spine, LLC K241468維蒂威奇® 骨內系統Foundation Surgical Group, Inc.K232790KONG®-TL VBR 系統及 KONG® C VBR 系統Icotec AG K233359DOMINION可擴展椎體切除系統Astura Medical

官方來源

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