FDA 510(k)

ProLift 可擴展間隔系統

K 號：K250373 · 2025-04-09

決定日期2025-04-09

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

ProLift Expandable Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K250373. 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 ProLift Expandable Spacer System?

ProLift Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Life Spine, Inc.. The 510(k) number is K250373.

When did ProLift Expandable Spacer System receive FDA 510(k) clearance?

ProLift Expandable Spacer System received FDA 510(k) clearance on 2025-04-09, under 510(k) number K250373.

Who is the listed applicant for ProLift Expandable Spacer System?

FDA 510(k) 記錄將 Life Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ProLift Expandable Spacer System?

The FDA product code for ProLift Expandable Spacer System is MAX.

其他以 Life Spine, 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。

K261430TruLift可擴展系統 K260571SIMPACT 骨盆釘合系統 GX 運導儀器 K260837VersaLift 可擴充系統 K254274ARx® SAI植入系統 K253748生命脊柱ProLift & ProLift Lateral以及ProLift Lateral固定擴張間隔系統 K251502TruLift® 横向擴展式間隔與横向支撐板系統

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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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