FDA 510(k)

沃夫氏法前頸椎板系統

K 號：K240592 · 2024-05-24

決定日期2024-05-24

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Wolff's Law Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240592. 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 Wolff's Law Anterior Cervical Plate System?

Wolff's Law Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K240592.

When did Wolff's Law Anterior Cervical Plate System receive FDA 510(k) clearance?

Wolff's Law Anterior Cervical Plate System received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240592.

Who is the listed applicant for Wolff's Law Anterior Cervical Plate System?

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

What is the FDA product code for Wolff's Law Anterior Cervical Plate System?

The FDA product code for Wolff's Law Anterior Cervical Plate System is KWQ.

其他以 Spinal Simplicity, LLC 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。

K253250美國FDA認證 Minuteman® G6 MIS 融合板 K250001Patriot SI 嵌入系統 K232259Patriot-SI 背部植入系統 K234051美國米尼曼G5融合板；米尼曼G1（後融合板 /HA後融合板）；HA米尼曼G3-R MIS融合板；米尼曼G3/HA米尼曼G3 K231923Liberty SI 横向植入系統 K233527Minuteman G5 MIS融合板；Minuteman G1（後融合板 /HA後融合板）；HA Minuteman G3-R MIS融合板；Minuteman G3/HA Minuteman G3 MIS融合板

查看所有 12 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。