亮盾
K 號：K181099 · 2019-01-18
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器材摘要
Bright Guard is the device name listed in this FDA 510(k) record. The listed applicant is Koncept Innovators, LLC. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K181099. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Bright Guard?
Bright Guard is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Koncept Innovators, LLC. The 510(k) number is K181099.
When did Bright Guard receive FDA 510(k) clearance?
Bright Guard received FDA 510(k) clearance on 2019-01-18, under 510(k) number K181099.
Who is the listed applicant for Bright Guard?
The FDA 510(k) record lists Koncept Innovators, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bright Guard?
The FDA product code for Bright Guard is OBR. This falls under the Orthopedic category.
相關臨床試驗
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其他以 Koncept Innovators, 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：OBR）
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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