FDA 510(k)

頸椎骨板系統固定解決方案（CSTS-PS）

K 號：K212527 · 2022-05-17

決定日期2022-05-17

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Cervical Spine Truss System Plating Solution (CSTS-PS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K212527. 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 Cervical Spine Truss System Plating Solution (CSTS-PS)?

Cervical Spine Truss System Plating Solution (CSTS-PS) is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K212527.

When did Cervical Spine Truss System Plating Solution (CSTS-PS) receive FDA 510(k) clearance?

Cervical Spine Truss System Plating Solution (CSTS-PS) received FDA 510(k) clearance on 2022-05-17, under 510(k) number K212527.

Who is the listed applicant for Cervical Spine Truss System Plating Solution (CSTS-PS)?

The FDA 510(k) record lists 4Web Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Spine Truss System Plating Solution (CSTS-PS)?

The FDA product code for Cervical Spine Truss System Plating Solution (CSTS-PS) is KWQ.

其他以 4Web Medical, 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。

K253200頸椎支撐系統 - 独立型（CSTS-SA）K240388骨切架系統（OTS）K233966前脊柱支架系統-獨立型（ASTS-SA）K230088踝關節支具系統 (ATS)K231739頸椎支具系統（CSTS）K223362頸椎骨盆系統 - 独立型（CSTS-SA）椎間融合設備

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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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