FDA 510(k)

CastleLoc-P 頸椎前方板系統，AccelFix 腰椎板系統

K 號：K231839 · 2023-07-19

決定日期2023-07-19

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231839. 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 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K231839.

When did CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System receive FDA 510(k) clearance?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231839.

Who is the listed applicant for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

FDA 510(k) 記錄將 L&K BIOMED Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

The FDA product code for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is KWQ.

其他以 L&K BIOMED Co., Ltd. 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。

K262489BluEX 頸椎擴張籠系統 K260840BluEX 頸椎擴張籠系統 K261112CastleLoc-P 頸椎前方板系統 K261130AccelFix 骨折固定系統 K260448CastleLoc 胸廓條件系統 K251940PathLoc 腰椎板系統

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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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