FDA 510(k)

Exceed®雙平面擴張式椎間融合系統

K 號：K261159 · 2026-05-29

決定日期2026-05-29

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Exceed® Biplanar Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K261159. 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 Exceed® Biplanar Expandable Interbody System?

Exceed® Biplanar Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Spine Wave, Inc.. The 510(k) number is K261159.

When did Exceed® Biplanar Expandable Interbody System receive FDA 510(k) clearance?

Exceed® Biplanar Expandable Interbody System received FDA 510(k) clearance on 2026-05-29, under 510(k) number K261159.

Who is the listed applicant for Exceed® Biplanar Expandable Interbody System?

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

What is the FDA product code for Exceed® Biplanar Expandable Interbody System?

The FDA product code for Exceed® Biplanar Expandable Interbody System is MAX.

其他以 Spine Wave, 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。

K260286Dynamo™脊椎水泥；Salvo®脊椎系統 K243816Testa TP 旋轉間隔系統 K251131Annex® 2 邻近層級系統 K243514Salvo®機器人導航儀器 K240685Salvo®脊椎系統 K231275Exceed™雙平面擴展式椎間融合系統

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。