Genostis 骨固定系統
K 號：K242988 · 2025-06-27
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器材摘要
Genostis Osteosynthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Genostis AF. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K242988. 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 Genostis Osteosynthesis System?
Genostis Osteosynthesis System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Genostis AF. The 510(k) number is K242988.
When did Genostis Osteosynthesis System receive FDA 510(k) clearance?
Genostis Osteosynthesis System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K242988.
Who is the listed applicant for Genostis Osteosynthesis System?
The FDA 510(k) record lists Genostis AF as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Genostis Osteosynthesis System?
The FDA product code for Genostis Osteosynthesis System 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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