預美Spine XL儀器
K 號：K191854 · 2019-10-08
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器材摘要
Premia Spine XL Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191854. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Premia Spine XL Instruments?
Premia Spine XL Instruments is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Premia Spine, Ltd.. The 510(k) number is K191854.
When did Premia Spine XL Instruments receive FDA 510(k) clearance?
Premia Spine XL Instruments received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191854.
Who is the listed applicant for Premia Spine XL Instruments?
The FDA 510(k) record lists Premia Spine, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Premia Spine XL Instruments?
The FDA product code for Premia Spine XL Instruments is OLO.
相關臨床試驗
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其他以 Premia Spine, Ltd. 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。
相關器械（代碼：OLO）
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。
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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