OrthoGold 100
K 號：K200926 · 2020-08-28
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器材摘要
OrthoGold 100 is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, LLC. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K200926. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OrthoGold 100?
OrthoGold 100 is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Tissue Regeneration Technologies, LLC. The 510(k) number is K200926.
When did OrthoGold 100 receive FDA 510(k) clearance?
OrthoGold 100 received FDA 510(k) clearance on 2020-08-28, under 510(k) number K200926.
Who is the listed applicant for OrthoGold 100?
The FDA 510(k) record lists Tissue Regeneration Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OrthoGold 100?
The FDA product code for OrthoGold 100 is PZL.
相關臨床試驗
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其他以 Tissue Regeneration Technologies, LLC 為申請人之記錄
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：PZL）
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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