骨點脊椎氣球
K 號：K200763 · 2020-08-12
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器材摘要
Osteo-site Vertebral Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K200763. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Osteo-site Vertebral Balloon?
Osteo-site Vertebral Balloon is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Izi Medical. The 510(k) number is K200763.
When did Osteo-site Vertebral Balloon receive FDA 510(k) clearance?
Osteo-site Vertebral Balloon received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200763.
Who is the listed applicant for Osteo-site Vertebral Balloon?
The FDA 510(k) record lists Izi Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Osteo-site Vertebral Balloon?
The FDA product code for Osteo-site Vertebral Balloon is HRX.
相關臨床試驗
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相關器械（代碼：HRX）
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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