Gexfix 外固定設備
K 號：K160972 · 2016-12-28
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器材摘要
Gexfix External Fixation is the device name listed in this FDA 510(k) record. The listed applicant is Gexfix International Corp.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K160972. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Gexfix External Fixation?
Gexfix External Fixation is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Gexfix International Corp.. The 510(k) number is K160972.
When did Gexfix External Fixation receive FDA 510(k) clearance?
Gexfix External Fixation received FDA 510(k) clearance on 2016-12-28, under 510(k) number K160972.
Who is the listed applicant for Gexfix External Fixation?
The FDA 510(k) record lists Gexfix International Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gexfix External Fixation?
The FDA product code for Gexfix External Fixation is KTT.
相關臨床試驗
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相關器械（代碼：KTT）
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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