XO1 適膝平衡系統
K 號：K162237 · 2017-04-25
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器材摘要
XO1 Knee Balancing System is the device name listed in this FDA 510(k) record. The listed applicant is Xpandortho, Inc.. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162237. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the XO1 Knee Balancing System?
XO1 Knee Balancing System is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Xpandortho, Inc.. The 510(k) number is K162237.
When did XO1 Knee Balancing System receive FDA 510(k) clearance?
XO1 Knee Balancing System received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162237.
Who is the listed applicant for XO1 Knee Balancing System?
The FDA 510(k) record lists Xpandortho, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XO1 Knee Balancing System?
The FDA product code for XO1 Knee Balancing System is ONN.
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相關器械（代碼：ONN）
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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