FDA 510(k)

X-PAC® N-GAGE™ 腰椎板系統

K 號：K250602 · 2025-05-20

決定日期2025-05-20

產品代碼KWQ

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決定相當於

器材摘要

X-PAC® N-GAGE™ Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250602. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X-PAC® N-GAGE™ Lumbar Plate System?

X-PAC® N-GAGE™ Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Expanding Innovations, Inc.. The 510(k) number is K250602.

When did X-PAC® N-GAGE™ Lumbar Plate System receive FDA 510(k) clearance?

X-PAC® N-GAGE™ Lumbar Plate System received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250602.

Who is the listed applicant for X-PAC® N-GAGE™ Lumbar Plate System?

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

What is the FDA product code for X-PAC® N-GAGE™ Lumbar Plate System?

The FDA product code for X-PAC® N-GAGE™ Lumbar Plate System is KWQ.

其他以 Expanding Innovations, Inc. 為申請人之記錄

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相關器械（代碼：KWQ）

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。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLC K252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

官方來源

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