生物球MIS膠 (生物球MIS)
K 號：K173301 · 2018-01-19
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器材摘要
BioSphere MIS Putty (BioSphere MIS) is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Biomedical, LLC. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173301. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BioSphere MIS Putty (BioSphere MIS)?
BioSphere MIS Putty (BioSphere MIS) is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Synergy Biomedical, LLC. The 510(k) number is K173301.
When did BioSphere MIS Putty (BioSphere MIS) receive FDA 510(k) clearance?
BioSphere MIS Putty (BioSphere MIS) received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173301.
Who is the listed applicant for BioSphere MIS Putty (BioSphere MIS)?
The FDA 510(k) record lists Synergy Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioSphere MIS Putty (BioSphere MIS)?
The FDA product code for BioSphere MIS Putty (BioSphere MIS) is MQV.
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：MQV）
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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