FDA 510(k)

Ventana® P/T 腰椎間盤系統

K 號：K260506 · 2026-05-15

決定日期2026-05-15

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Ventana® P/T Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K260506. 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 Ventana® P/T Lumbar Interbody System?

Ventana® P/T Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K260506.

When did Ventana® P/T Lumbar Interbody System receive FDA 510(k) clearance?

Ventana® P/T Lumbar Interbody System received FDA 510(k) clearance on 2026-05-15, under 510(k) number K260506.

Who is the listed applicant for Ventana® P/T Lumbar Interbody System?

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

What is the FDA product code for Ventana® P/T Lumbar Interbody System?

The FDA product code for Ventana® P/T Lumbar Interbody System is MAX.

其他以 Spinal Elements, 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。

K253559Ventana™ A 前腰椎間體系統 K250773Luna® 間體融合系統 K242527Karma®固定系統 K243916普瑞斯脊椎固定系統 K231593Sapphire X3 頸椎前方板系統 K231252Ventana™ L 腰椎系統

查看所有 24 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。