週邊C（钛）脊柱系統
K 號：K153438 · 2016-03-02
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器材摘要
PERIMETER C (Titanium) Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K153438. 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 PERIMETER C (Titanium) Spinal System?
PERIMETER C (Titanium) Spinal System is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K153438.
When did PERIMETER C (Titanium) Spinal System receive FDA 510(k) clearance?
PERIMETER C (Titanium) Spinal System received FDA 510(k) clearance on 2016-03-02, under 510(k) number K153438.
Who is the listed applicant for PERIMETER C (Titanium) Spinal System?
FDA 510(k) 記錄將美敦力索法莫丹克美國，股份有限公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for PERIMETER C (Titanium) Spinal System?
The FDA product code for PERIMETER C (Titanium) Spinal System is ODP.
相關臨床試驗
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其他以 Medtronic Sofamor Danek USA, Inc. 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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