The BioBrace 假裝置 FDA、510(k)、PMA、NCT、PMID、識別碼及網址請保持原樣。
K 號：K203267 · 2021-04-30
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器材摘要
The BioBrace Implant is the device name listed in this FDA 510(k) record. The listed applicant is Biorez, Inc.. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K203267. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the The BioBrace Implant?
The BioBrace Implant is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Biorez, Inc.. The 510(k) number is K203267.
When did The BioBrace Implant receive FDA 510(k) clearance?
The BioBrace Implant received FDA 510(k) clearance on 2021-04-30, under 510(k) number K203267.
Who is the listed applicant for The BioBrace Implant?
The FDA 510(k) record lists Biorez, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The BioBrace Implant?
The FDA product code for The BioBrace Implant is OWW.
相關臨床試驗
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相關器械（代碼：OWW）
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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