REDUCT® 頭無壓縮螺釘系統
K 號：K201662 · 2020-07-16
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器材摘要
REDUCT® Headless Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K201662. 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 REDUCT® Headless Compression Screw System?
REDUCT® Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K201662.
When did REDUCT® Headless Compression Screw System receive FDA 510(k) clearance?
REDUCT® Headless Compression Screw System received FDA 510(k) clearance on 2020-07-16, under 510(k) number K201662.
Who is the listed applicant for REDUCT® Headless Compression Screw System?
FDA 510(k) 記錄將 Skeletal Dynamics, 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 REDUCT® Headless Compression Screw System?
The FDA product code for REDUCT® Headless Compression Screw System is HWC. This falls under the Cardiovascular category.
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 Skeletal Dynamics, 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：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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