COSINE™ 間隔器
K 號：K234035 · 2024-09-06
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器材摘要
COSINE™ Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K234035. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the COSINE™ Spacer?
COSINE™ Spacer is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K234035.
When did COSINE™ Spacer receive FDA 510(k) clearance?
COSINE™ Spacer received FDA 510(k) clearance on 2024-09-06, under 510(k) number K234035.
Who is the listed applicant for COSINE™ Spacer?
FDA 510(k) 記錄將 Globus Medical, Inc. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for COSINE™ Spacer?
The FDA product code for COSINE™ Spacer is MAX.
相關臨床試驗
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其他以 Globus Medical, 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：MAX）
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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