VK100 體外椎骨增壓系統
K 號：K192403 · 2019-11-08
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器材摘要
VK100 Percutaneous Vertebral Augmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Bonwrx, Ltd.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K192403. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VK100 Percutaneous Vertebral Augmentation System?
VK100 Percutaneous Vertebral Augmentation System is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Bonwrx, Ltd.. The 510(k) number is K192403.
When did VK100 Percutaneous Vertebral Augmentation System receive FDA 510(k) clearance?
VK100 Percutaneous Vertebral Augmentation System received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192403.
Who is the listed applicant for VK100 Percutaneous Vertebral Augmentation System?
The FDA 510(k) record lists Bonwrx, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VK100 Percutaneous Vertebral Augmentation System?
The FDA product code for VK100 Percutaneous Vertebral Augmentation System is NDN.
相關臨床試驗
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相關器械（代碼：NDN）
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
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