DAC動態活壓板
K 號：K200513 · 2020-07-22
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器材摘要
DAC Dynamic Active Compression Plate is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K200513. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DAC Dynamic Active Compression Plate?
DAC Dynamic Active Compression Plate is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical. The 510(k) number is K200513.
When did DAC Dynamic Active Compression Plate receive FDA 510(k) clearance?
DAC Dynamic Active Compression Plate received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200513.
Who is the listed applicant for DAC Dynamic Active Compression Plate?
The FDA 510(k) record lists Pioneer Surgical Technology, Inc., Dba Rti Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DAC Dynamic Active Compression Plate?
The FDA product code for DAC Dynamic Active Compression Plate is HRS.
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。
相關器械（代碼：HRS）
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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