FDA 510(k)

前脊柱支架系統-獨立型（ASTS-SA）

K 號：K233966 · 2024-04-22

決定日期2024-04-22

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Anterior Spine Truss System-Stand Alone (ASTS-SA) 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 2024-04-22 under 510(k) number K233966. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anterior Spine Truss System-Stand Alone (ASTS-SA)?

Anterior Spine Truss System-Stand Alone (ASTS-SA) is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K233966.

When did Anterior Spine Truss System-Stand Alone (ASTS-SA) receive FDA 510(k) clearance?

Anterior Spine Truss System-Stand Alone (ASTS-SA) received FDA 510(k) clearance on 2024-04-22, under 510(k) number K233966.

Who is the listed applicant for Anterior Spine Truss System-Stand Alone (ASTS-SA)?

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 Anterior Spine Truss System-Stand Alone (ASTS-SA)?

The FDA product code for Anterior Spine Truss System-Stand Alone (ASTS-SA) is OVD.

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）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 K221266頸椎骨盆系統（CSTS）間體融合裝置

查看所有 11 項裝置 →

相關器械（代碼：OVD）

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA Innovasis K261408SABER-XA 系統Elevation Spine K261809Interwedge® 独立側邊架Foundation Surgical Group K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLC K254202MectaLIF 3D金屬前臍Medacta International S.A.

官方來源

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