FDA 510(k)

側位脊椎支撐系統（LSTS）椎間融合設備

K 號：K172392 · 2017-11-07

決定日期2017-11-07

產品代碼MAX

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決定相當於

器材摘要

Lateral Spinal Truss System (LSTS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2017-11-07 under 510(k) number K172392. 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 Spinal Truss System (LSTS) Interbody Fusion Device?

Lateral Spinal Truss System (LSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-11-07. The listed applicant is 4Web, Inc.. The 510(k) number is K172392.

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

Lateral Spinal Truss System (LSTS) Interbody Fusion Device received FDA 510(k) clearance on 2017-11-07, under 510(k) number K172392.

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

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 Lateral Spinal Truss System (LSTS) Interbody Fusion Device?

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

其他以 4Web, Inc. 為申請人之記錄

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K253201腰椎脊柱支架系統 - 鋼板解決方案（LSTS-PS）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）

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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

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