FDA 510(k)

Elegance® 前頸板

K 號：K243904 · 2025-01-14

決定日期2025-01-14

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Elegance® Anterior Cervical plate is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K243904. 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 Elegance® Anterior Cervical plate?

Elegance® Anterior Cervical plate is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Clariance. The 510(k) number is K243904.

When did Elegance® Anterior Cervical plate receive FDA 510(k) clearance?

Elegance® Anterior Cervical plate received FDA 510(k) clearance on 2025-01-14, under 510(k) number K243904.

Who is the listed applicant for Elegance® Anterior Cervical plate?

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

What is the FDA product code for Elegance® Anterior Cervical plate?

The FDA product code for Elegance® Anterior Cervical plate is KWQ.

其他以 Clariance 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。

K243670Idys® LIF K241863Erisma® Lp脊椎固定系統；Erisma® LP MIS K240872Erisma® 叭曲脊椎系統；Erisma® Lp 脊椎固定系統 K240715Idys® C ZP 3DTi K220182Aggeris™-C K200919Idys ALIF 3DTi

查看所有 7 項裝置 →

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

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。