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FDA 510(k)

PRADO™ 腰椎間融合系統

K 號：K252113 · 2025-08-05

申請人Bethesda Medical Devices
決定日期2025-08-05
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

PRADO™ Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Bethesda Medical Devices. It received FDA 510(k) clearance on 2025-08-05 under 510(k) number K252113. 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 PRADO™ Lumbar Interbody Fusion System?

PRADO™ Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Bethesda Medical Devices. The 510(k) number is K252113.

When did PRADO™ Lumbar Interbody Fusion System receive FDA 510(k) clearance?

PRADO™ Lumbar Interbody Fusion System received FDA 510(k) clearance on 2025-08-05, under 510(k) number K252113.

Who is the listed applicant for PRADO™ Lumbar Interbody Fusion System?

The FDA 510(k) record lists Bethesda Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRADO™ Lumbar Interbody Fusion System?

The FDA product code for PRADO™ Lumbar Interbody Fusion System is MAX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 SAK261430TruLift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 CorporationK253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

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