GBR系統
K 號：K170697 · 2018-05-24
廣告
器材摘要
GBR system is the device name listed in this FDA 510(k) record. The listed applicant is Surgident. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K170697. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GBR system?
GBR system is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Surgident. The 510(k) number is K170697.
When did GBR system receive FDA 510(k) clearance?
GBR system received FDA 510(k) clearance on 2018-05-24, under 510(k) number K170697.
Who is the listed applicant for GBR system?
The FDA 510(k) record lists Surgident as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GBR system?
The FDA product code for GBR system is JEY.
相關臨床試驗
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。
相關器械（代碼：JEY）
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。
K260137KLS Martin IPS 口腔-馬克斯植入物 - MR條件性；個人患者解決方案 - Ti (IPS-Ti)；個人患者解決方案 - PEEK (IPS-PEEK)；KLS Martin 個人患者解決方案KLS-Martin L.P.K253206謹慎個別化CMF解決方案Meticuly Co., Ltd.K252246萊福特MMF系統Jeil Medical CorporationK253373南頸顎面骨系統Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 婴兒生物可吸收固定系統；Inion CPS 1.5/2.0/2.5 生物可吸收固定系統Inion OYK241314KLS Martin 口腔-馬克斯植入物 MR條件性（組合式）KLS-Martin L.P.
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。
廣告