PROstep™ MIS 5mm 開槽螺釘系統
K 號：K221645 · 2023-02-17
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器材摘要
PROstep(TM) MIS 5mm Chamfer Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221645. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the PROstep(TM) MIS 5mm Chamfer Screw System?
PROstep(TM) MIS 5mm Chamfer Screw System is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Wright Medical Technology. The 510(k) number is K221645.
When did PROstep(TM) MIS 5mm Chamfer Screw System receive FDA 510(k) clearance?
PROstep(TM) MIS 5mm Chamfer Screw System received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221645.
Who is the listed applicant for PROstep(TM) MIS 5mm Chamfer Screw System?
The FDA 510(k) record lists Wright Medical Technology as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System?
The FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System is HWC. This falls under the Cardiovascular category.
相關臨床試驗
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相關器械（代碼：HWC）
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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