Traufix骨固定、骨斷裂及關節融合設備
K 號：K201510 · 2022-02-18
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器材摘要
Traufix osteosynthesis, osteotomy, and arthrodesis devices is the device name listed in this FDA 510(k) record. The listed applicant is Fixier S.A. DE C.V.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K201510. 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 Traufix osteosynthesis, osteotomy, and arthrodesis devices?
Traufix osteosynthesis, osteotomy, and arthrodesis devices is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Fixier S.A. DE C.V.. The 510(k) number is K201510.
When did Traufix osteosynthesis, osteotomy, and arthrodesis devices receive FDA 510(k) clearance?
Traufix osteosynthesis, osteotomy, and arthrodesis devices received FDA 510(k) clearance on 2022-02-18, under 510(k) number K201510.
Who is the listed applicant for Traufix osteosynthesis, osteotomy, and arthrodesis devices?
The FDA 510(k) record lists Fixier S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Traufix osteosynthesis, osteotomy, and arthrodesis devices?
The FDA product code for Traufix osteosynthesis, osteotomy, and arthrodesis devices 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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