Kyphon HV-R Bone Cement
K 號：K160983 · 2016-08-24
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器材摘要
Kyphon HV-R Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-08-24 under 510(k) number K160983. 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 Kyphon HV-R Bone Cement?
Kyphon HV-R Bone Cement is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Medtronic, Inc.. The 510(k) number is K160983.
When did Kyphon HV-R Bone Cement receive FDA 510(k) clearance?
Kyphon HV-R Bone Cement received FDA 510(k) clearance on 2016-08-24, under 510(k) number K160983.
Who is the listed applicant for Kyphon HV-R Bone Cement?
The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kyphon HV-R Bone Cement?
The FDA product code for Kyphon HV-R Bone Cement is NDN.
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其他以 Medtronic, Inc. 為申請人之記錄
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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。
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官方來源
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