FDA 510(k)

近端前頸板系統；節段性板金系統（SPS）

K 號：K251965 · 2025-08-28

決定日期2025-08-28

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251965. 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 Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K251965.

When did Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) receive FDA 510(k) clearance?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251965.

Who is the listed applicant for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

FDA 510(k) 記錄將 Alphatec 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 Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

The FDA product code for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is KWQ.

其他以 Alphatec 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。

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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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