KeriFlex® MCP及PIP手指關節義肢
K 號：K211385 · 2022-07-27
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器材摘要
KeriFlex® MCP and PIP Finger Joint Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Keri Medical SA. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K211385. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the KeriFlex® MCP and PIP Finger Joint Prostheses?
KeriFlex® MCP and PIP Finger Joint Prostheses is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Keri Medical SA. The 510(k) number is K211385.
When did KeriFlex® MCP and PIP Finger Joint Prostheses receive FDA 510(k) clearance?
KeriFlex® MCP and PIP Finger Joint Prostheses received FDA 510(k) clearance on 2022-07-27, under 510(k) number K211385.
Who is the listed applicant for KeriFlex® MCP and PIP Finger Joint Prostheses?
The FDA 510(k) record lists Keri Medical SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses?
The FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses is KYJ.
相關臨床試驗
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相關器械（代碼：KYJ）
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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