RESPONSE™ 肋骨及骨盆系統
K 號：K233105 · 2024-01-20
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器材摘要
RESPONSE™ Rib and Pelvic System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2024-01-20 under 510(k) number K233105. The device is classified under product code MDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RESPONSE™ Rib and Pelvic System?
RESPONSE™ Rib and Pelvic System is a medical device that received FDA 510(k) clearance on 2024-01-20. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K233105.
When did RESPONSE™ Rib and Pelvic System receive FDA 510(k) clearance?
RESPONSE™ Rib and Pelvic System received FDA 510(k) clearance on 2024-01-20, under 510(k) number K233105.
Who is the listed applicant for RESPONSE™ Rib and Pelvic System?
FDA 510(k) 記錄將 OrthoPediatrics Corp. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for RESPONSE™ Rib and Pelvic System?
The FDA product code for RESPONSE™ Rib and Pelvic System is MDI.
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。
其他以 OrthoPediatrics Corp. 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。
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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