FDA 510(k)

側脊柱橋樑系統（LSTS）內固定融合設備

K 號：K211388 · 2021-08-05

決定日期2021-08-05

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Lateral Spine Truss System (LSTS) Interbody Fusion Device 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 2021-08-05 under 510(k) number K211388. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lateral Spine Truss System (LSTS) Interbody Fusion Device?

Lateral Spine Truss System (LSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K211388.

When did Lateral Spine Truss System (LSTS) Interbody Fusion Device receive FDA 510(k) clearance?

Lateral Spine Truss System (LSTS) Interbody Fusion Device received FDA 510(k) clearance on 2021-08-05, under 510(k) number K211388.

Who is the listed applicant for Lateral Spine Truss System (LSTS) Interbody Fusion Device?

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 Lateral Spine Truss System (LSTS) Interbody Fusion Device?

The FDA product code for Lateral Spine Truss System (LSTS) Interbody Fusion Device is MAX.

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

查看所有 11 項裝置 →

相關器械（代碼：MAX）

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。

K261049SCALA® TLSpineart SA K261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

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。