X-BOLT 髋骨骨折固定系統
K 號：K181640 · 2018-10-12
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器材摘要
X-BOLT Hip Fracture Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Bolt Orthopaedics. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181640. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the X-BOLT Hip Fracture Fixation System?
X-BOLT Hip Fracture Fixation System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is X-Bolt Orthopaedics. The 510(k) number is K181640.
When did X-BOLT Hip Fracture Fixation System receive FDA 510(k) clearance?
X-BOLT Hip Fracture Fixation System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181640.
Who is the listed applicant for X-BOLT Hip Fracture Fixation System?
The FDA 510(k) record lists X-Bolt Orthopaedics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-BOLT Hip Fracture Fixation System?
The FDA product code for X-BOLT Hip Fracture Fixation System is HSB.
相關臨床試驗
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相關器械（代碼：HSB）
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。
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官方來源
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