雙倍X
K 號：K181397 · 2018-09-27
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器材摘要
DualX is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive, Inc.. It received FDA 510(k) clearance on 2018-09-27 under 510(k) number K181397. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DualX?
DualX is a medical device that received FDA 510(k) clearance on 2018-09-27. The listed applicant is Innovasive, Inc.. The 510(k) number is K181397.
When did DualX receive FDA 510(k) clearance?
DualX received FDA 510(k) clearance on 2018-09-27, under 510(k) number K181397.
Who is the listed applicant for DualX?
The FDA 510(k) record lists Innovasive, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DualX?
The FDA product code for DualX is MAX.
相關臨床試驗
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相關器械（代碼：MAX）
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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