聯合骨科膝關節病人專屬儀器
K 號：K230850 · 2023-12-20
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器材摘要
United Orthopedic Knee Patient Specific Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Enhatch, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K230850. The device is classified under product code OOG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the United Orthopedic Knee Patient Specific Instrumentation?
United Orthopedic Knee Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Enhatch, Inc.. The 510(k) number is K230850.
When did United Orthopedic Knee Patient Specific Instrumentation receive FDA 510(k) clearance?
United Orthopedic Knee Patient Specific Instrumentation received FDA 510(k) clearance on 2023-12-20, under 510(k) number K230850.
Who is the listed applicant for United Orthopedic Knee Patient Specific Instrumentation?
The FDA 510(k) record lists Enhatch, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for United Orthopedic Knee Patient Specific Instrumentation?
The FDA product code for United Orthopedic Knee Patient Specific Instrumentation is OOG.
相關臨床試驗
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相關器械（代碼：OOG）
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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