AnyPlus® 頸椎 PEEK 金屬網架系統
K 號：K153517 · 2016-06-24
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器材摘要
AnyPlus® Cervical PEEK Cage System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K153517. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AnyPlus® Cervical PEEK Cage System?
AnyPlus® Cervical PEEK Cage System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K153517.
When did AnyPlus® Cervical PEEK Cage System receive FDA 510(k) clearance?
AnyPlus® Cervical PEEK Cage System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K153517.
Who is the listed applicant for AnyPlus® Cervical PEEK Cage System?
FDA 510(k)記錄將GS Medical Co., Ltd.列為申請人。這本身並不足以確立設備製造商。
What is the FDA product code for AnyPlus® Cervical PEEK Cage System?
The FDA product code for AnyPlus® Cervical PEEK Cage System is ODP.
相關臨床試驗
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其他以 GS Medical Co., Ltd. 為申請人之記錄
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：ODP）
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
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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