FDA 510(k)

NuVasive Cohere ALIF 系統脊椎間融合設備

K 號：K221751 · 2022-10-21

決定日期2022-10-21

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

NuVasive Cohere ALIF System Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K221751. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NuVasive Cohere ALIF System Intervertebral Body Fusion Device?

NuVasive Cohere ALIF System Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K221751.

When did NuVasive Cohere ALIF System Intervertebral Body Fusion Device receive FDA 510(k) clearance?

NuVasive Cohere ALIF System Intervertebral Body Fusion Device received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221751.

Who is the listed applicant for NuVasive Cohere ALIF System Intervertebral Body Fusion Device?

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

What is the FDA product code for NuVasive Cohere ALIF System Intervertebral Body Fusion Device?

The FDA product code for NuVasive Cohere ALIF System Intervertebral Body Fusion Device is OVD.

其他以 Nu Vasive, Incorporated 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。

K231735NuVasive CoRoent 小型間體系統；NuVasive CoRoent 小型曲面間體系統；NuVasive CoRoent 小型互鎖系統；NuVasive CoRoent 小型互鎖II系統；NuVasive CoRoent 小型Ti-C系統；NuVasive Cohere 頸椎間體系統 K230894NuVasive Modulus ALIF 系統 K230989醫療設備註冊框架 K223181NuVasive Reline 系統 K221388NuVasive Reline 頸椎系統 K220478NuVasive MOD-EX XLIF 間置系統，NuVasive MOD-EX XLIF 鋼板 2.0 間置系統

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相關器械（代碼：OVD）

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA Innovasis K261408SABER-XA 系統Elevation Spine K261809Interwedge® 独立側邊架Foundation Surgical Group K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLC K254202MectaLIF 3D金屬前臍Medacta International S.A.

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