帕尼頓醫療平衡植板系統
K 號：K162154 · 2017-04-24
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器材摘要
Pantheon Medical Balanced Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Medical. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162154. 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 Pantheon Medical Balanced Plating System?
Pantheon Medical Balanced Plating System is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Pantheon Medical. The 510(k) number is K162154.
When did Pantheon Medical Balanced Plating System receive FDA 510(k) clearance?
Pantheon Medical Balanced Plating System received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162154.
Who is the listed applicant for Pantheon Medical Balanced Plating System?
The FDA 510(k) record lists Pantheon Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pantheon Medical Balanced Plating System?
The FDA product code for Pantheon Medical Balanced Plating System is HRS.
相關臨床試驗
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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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