FDA 510(k)

IB3D™ PL脊椎系統（A24000000 / IB3D通用植入物插入器）

K 號：K253577 · 2025-12-19

申請人Medicrea International S.A.S. (Medtronic)

決定日期2025-12-19

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253577. 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 IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Medicrea International S.A.S. (Medtronic). The 510(k) number is K253577.

When did IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) receive FDA 510(k) clearance?

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253577.

Who is the listed applicant for IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

The FDA 510(k) record lists Medicrea International S.A.S. (Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

The FDA product code for IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is MAX.

其他以 Medicrea International S.A.S. (Medtronic) 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。

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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。

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官方來源

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