OneLIF脊椎間置換系統
K 號：K211769 · 2021-09-07
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器材摘要
OneLIF Intervertebral Body Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Novapproach Spine. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K211769. 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 OneLIF Intervertebral Body Replacement System?
OneLIF Intervertebral Body Replacement System is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Novapproach Spine. The 510(k) number is K211769.
When did OneLIF Intervertebral Body Replacement System receive FDA 510(k) clearance?
OneLIF Intervertebral Body Replacement System received FDA 510(k) clearance on 2021-09-07, under 510(k) number K211769.
Who is the listed applicant for OneLIF Intervertebral Body Replacement System?
The FDA 510(k) record lists Novapproach Spine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OneLIF Intervertebral Body Replacement System?
The FDA product code for OneLIF Intervertebral Body Replacement System is OVD.
相關臨床試驗
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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。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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