FDA 510(k)

Atlas 腰椎擴張式椎間盤系統

K 號：K180675 · 2018-06-13

決定日期2018-06-13

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Atlas Spine Expandable Cervical Interbody 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 2018-06-13 under 510(k) number K180675. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atlas Spine Expandable Cervical Interbody System?

Atlas Spine Expandable Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K180675.

When did Atlas Spine Expandable Cervical Interbody System receive FDA 510(k) clearance?

Atlas Spine Expandable Cervical Interbody System received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180675.

Who is the listed applicant for Atlas Spine Expandable Cervical Interbody 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 Expandable Cervical Interbody System?

The FDA product code for Atlas Spine Expandable Cervical Interbody System is ODP.

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 K252560Atlas Spine HiRISE™ 可擴張頸椎椎體切除系統 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

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相關器械（代碼：ODP）

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。

K262595VariLift-C 頸椎間融合系統Wenzel Spine, Inc.K262489BluEX 頸椎擴張籠系統L&K BIOMED Co., Ltd.K2530413D籠架頸椎Fims Co., Ltd.K262061Tritanium® C 頸椎前方金層；Tritanium® PL 金層；Tritanium® TL 弯曲後腰金層；Aero® -C 頸椎金層系統；AVS® Anchor-C 頸椎金層系統；AVS® TL PEEK 间隔器；AVS® PL PEEK 间隔器；AVS® Navigator PEEK 间隔器；AVS® AS PEEK 间隔器；Monterey™ AL 間體系統；Aleutian IBF 系統；Cascadia 間體系統；Chesapeake 稳定系統；Sahara 稳定系統；SANTORINI™ 去骨金層系統；MOJAVE 間體系統；VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. 医療間體融合系統C.A. Medical, LLC K260840BluEX 頸椎擴張籠系統L&K BIOMED Co., Ltd.

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