XD880A 超聲骨切術術後系統
K 號：K172464 · 2018-04-24
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器材摘要
XD880A Ultrasonic Osteotomy Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Morley Research Consortium. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K172464. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the XD880A Ultrasonic Osteotomy Surgical System?
XD880A Ultrasonic Osteotomy Surgical System is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Morley Research Consortium. The 510(k) number is K172464.
When did XD880A Ultrasonic Osteotomy Surgical System receive FDA 510(k) clearance?
XD880A Ultrasonic Osteotomy Surgical System received FDA 510(k) clearance on 2018-04-24, under 510(k) number K172464.
Who is the listed applicant for XD880A Ultrasonic Osteotomy Surgical System?
The FDA 510(k) record lists Morley Research Consortium as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XD880A Ultrasonic Osteotomy Surgical System?
The FDA product code for XD880A Ultrasonic Osteotomy Surgical System is JDX.
相關臨床試驗
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相關器械（代碼：JDX）
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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