FDA 510(k)

Ascend VBR系統, Ascend NanoTec VBR系統

K 號：K232173 · 2023-10-06

決定日期2023-10-06

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

Ascend VBR System, Ascend NanoTec VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232173. 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 Ascend VBR System, Ascend NanoTec VBR System?

Ascend VBR System, Ascend NanoTec VBR System is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232173.

When did Ascend VBR System, Ascend NanoTec VBR System receive FDA 510(k) clearance?

Ascend VBR System, Ascend NanoTec VBR System received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232173.

Who is the listed applicant for Ascend VBR System, Ascend NanoTec VBR System?

FDA 510(k) 記錄將 Alphatec Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ascend VBR System, Ascend NanoTec VBR System?

The FDA product code for Ascend VBR System, Ascend NanoTec VBR System is MQP.

其他以 Alphatec Spine, Inc. 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。

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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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