OneLIF™ 間隙融合系統
K 號：K251459 · 2025-06-12
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器材摘要
OneLIF™ Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Novapproach Spine, LLC. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251459. 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™ Interbody Fusion System?
OneLIF™ Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Novapproach Spine, LLC. The 510(k) number is K251459.
When did OneLIF™ Interbody Fusion System receive FDA 510(k) clearance?
OneLIF™ Interbody Fusion System received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251459.
Who is the listed applicant for OneLIF™ Interbody Fusion System?
The FDA 510(k) record lists Novapproach Spine, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OneLIF™ Interbody Fusion System?
The FDA product code for OneLIF™ Interbody Fusion System is OVD.
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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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