VCFix脊椎系統
K 號：K250637 · 2025-05-30
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器材摘要
VCFix Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Amber Implants. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250637. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VCFix Spinal System?
VCFix Spinal System is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Amber Implants. The 510(k) number is K250637.
When did VCFix Spinal System receive FDA 510(k) clearance?
VCFix Spinal System received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250637.
Who is the listed applicant for VCFix Spinal System?
The FDA 510(k) record lists Amber Implants as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VCFix Spinal System?
The FDA product code for VCFix Spinal System is NDN.
相關臨床試驗
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相關器械（代碼：NDN）
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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