ClearPoint 骨螺釘標記點
K 號：K233144 · 2024-01-12
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器材摘要
ClearPoint Bone Screw Fiducials is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233144. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ClearPoint Bone Screw Fiducials?
ClearPoint Bone Screw Fiducials is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233144.
When did ClearPoint Bone Screw Fiducials receive FDA 510(k) clearance?
ClearPoint Bone Screw Fiducials received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233144.
Who is the listed applicant for ClearPoint Bone Screw Fiducials?
The FDA 510(k) record lists ClearPoint Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClearPoint Bone Screw Fiducials?
The FDA product code for ClearPoint Bone Screw Fiducials is HAW.
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。
其他以 ClearPoint Neuro, 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：HAW）
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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