Para-Fix 外固定系統
K 號：K230067 · 2023-09-22
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器材摘要
Para-Fix External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is New Paradigm Biomedical. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K230067. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Para-Fix External Fixation System?
Para-Fix External Fixation System is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is New Paradigm Biomedical. The 510(k) number is K230067.
When did Para-Fix External Fixation System receive FDA 510(k) clearance?
Para-Fix External Fixation System received FDA 510(k) clearance on 2023-09-22, under 510(k) number K230067.
Who is the listed applicant for Para-Fix External Fixation System?
The FDA 510(k) record lists New Paradigm Biomedical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Para-Fix External Fixation System?
The FDA product code for Para-Fix External Fixation System is LXT.
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官方來源
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