FDA 510(k)

ORIO-Ti脊椎間融合金屬網架系統

K 號：K211935 · 2021-09-30

決定日期2021-09-30

產品代碼ODP

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決定相當於

器材摘要

ORIO-Ti Intervertebral Body Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K211935. 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 ORIO-Ti Intervertebral Body Fusion Cage System?

ORIO-Ti Intervertebral Body Fusion Cage System is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Spinecraft, LLC. The 510(k) number is K211935.

When did ORIO-Ti Intervertebral Body Fusion Cage System receive FDA 510(k) clearance?

ORIO-Ti Intervertebral Body Fusion Cage System received FDA 510(k) clearance on 2021-09-30, under 510(k) number K211935.

Who is the listed applicant for ORIO-Ti Intervertebral Body Fusion Cage System?

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

What is the FDA product code for ORIO-Ti Intervertebral Body Fusion Cage System?

The FDA product code for ORIO-Ti Intervertebral Body Fusion Cage System is ODP.

其他以 Spinecraft, LLC 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：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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