FDA 510(k)

腰椎脊柱支架系統 - 鋼板解決方案（LSTS-PS）

K 號：K253201 · 2026-02-12

決定日期2026-02-12

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Lumbar Spine Truss System - Plating Solution (LSTS-PS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K253201. 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 Lumbar Spine Truss System - Plating Solution (LSTS-PS)?

Lumbar Spine Truss System - Plating Solution (LSTS-PS) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is 4Web, Inc.. The 510(k) number is K253201.

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

Lumbar Spine Truss System - Plating Solution (LSTS-PS) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253201.

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

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

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

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

其他以 4Web, 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。

K203065腰椎脊柱支架系統板金解決方案（LSTS-PS）K200002前脊柱支架系統 – 独立型（ASTS-SA）椎間融合設備 K190870頸椎脊柱支撐系統-獨立型（CSTS-SA）K190926鍵節固定系統（HTS）K172294骨切架系統（OTS）K173159頸椎脊柱支撐系統（Cervical Spinal Truss System, CSTS）內固定融合裝置

查看所有 11 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

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