內骨骼TCS間體融合設備
K 號：K191565 · 2019-08-06
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器材摘要
Endoskeleton TCS Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Titan Spine, Inc.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K191565. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Endoskeleton TCS Interbody Fusion Device?
Endoskeleton TCS Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Titan Spine, Inc.. The 510(k) number is K191565.
When did Endoskeleton TCS Interbody Fusion Device receive FDA 510(k) clearance?
Endoskeleton TCS Interbody Fusion Device received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191565.
Who is the listed applicant for Endoskeleton TCS Interbody Fusion Device?
The FDA 510(k) record lists Titan Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endoskeleton TCS Interbody Fusion Device?
The FDA product code for Endoskeleton TCS Interbody Fusion Device is OVE.
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其他以 Titan Spine, Inc. 為申請人之記錄
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相關器械（代碼：OVE）
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
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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