FDA 510(k)

Atlas Spine HiRISE™ 可擴張頸椎椎體切除系統

K 號：K252560 · 2025-11-10

決定日期2025-11-10

產品代碼PLR

諮詢委員會或

決定相當於

器材摘要

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K252560. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atlas Spine HiRISE™ Expandable Cervical Corpectomy System?

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K252560.

When did Atlas Spine HiRISE™ Expandable Cervical Corpectomy System receive FDA 510(k) clearance?

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252560.

Who is the listed applicant for Atlas Spine HiRISE™ Expandable Cervical Corpectomy System?

FDA 510(k) 記錄將 Atlas 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 Atlas Spine HiRISE™ Expandable Cervical Corpectomy System?

The FDA product code for Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is PLR.

其他以 Atlas 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。

K252822Atlas脊椎HiRISE™可擴展頸椎前柱切除植入體 K251969Atlas Spine Project X 可擴張後腰部椎間系統 K243191Atlas Spine 横向可擴張椎間系統 K202302Atlas Spine Rebar (Ti) 空間器系統 K192570Atlas 腰椎擴張式椎間盤獨立系統 K182418V3 分段固定系統

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相關器械（代碼：PLR）

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。

K252822Atlas脊椎HiRISE™可擴展頸椎前柱切除植入體Atlas Spine, Inc.K232481RIGEL™ 3DR 頸部前方椎體切除系統MiRus, LLC K221542伽利略脊椎體置換設備Bright Spine K212126MediExpand 頸部擴張式VBR系統Cmf Medicon Surgical, Inc.K211320CAPRI 胸椎切除籠架系統K2m, Inc.K192145伽利略脊椎體置換設備Bright Spine

官方來源

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