FDA 510(k)

aprevo®脊椎板系統

K 號：K252611 · 2025-12-22

決定日期2025-12-22

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

aprevo® cervical plating system is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K252611. 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 aprevo® cervical plating system?

aprevo® cervical plating system is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Carlsmed, Inc.. The 510(k) number is K252611.

When did aprevo® cervical plating system receive FDA 510(k) clearance?

aprevo® cervical plating system received FDA 510(k) clearance on 2025-12-22, under 510(k) number K252611.

Who is the listed applicant for aprevo® cervical plating system?

FDA 510(k) 記錄將 Carlsmed, 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 aprevo® cervical plating system?

The FDA product code for aprevo® cervical plating system is KWQ.

其他以 Carlsmed, 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。

K262149corra®脊椎板系統 K260385aprevo® 前側及側方腰椎間融合系統；aprevo® 頸椎間融合系統；aprevo® 頸椎間融合系統；corra™ 頸椎板系統 K260570corra™脊椎板系統 K252894aprevo®脊椎間植入系統 K250827aprevo® 前腰椎間融合器；aprevo® 侧腰椎間融合器；aprevo® 帶內固定前腰椎間融合器；aprevo® 横突腰椎間融合器；aprevo® TLIF-CA 參節系統；aprevo® 頸椎 ACDF；aprevo® 頸椎 ACDF-X；aprevo® 頸椎 ACDF-X 不含針座 K250987aprevo® 頸椎/間孔腰椎間融合器

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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

官方來源

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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。