迷你骨針固定系統
K 號：K231443 · 2023-11-21
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器材摘要
Mini-OSTEO Pedicle Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Indústria E Comércio DE Implantes Ltda. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K231443. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Mini-OSTEO Pedicle Fixation System?
Mini-OSTEO Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Osteomed Indústria E Comércio DE Implantes Ltda. The 510(k) number is K231443.
When did Mini-OSTEO Pedicle Fixation System receive FDA 510(k) clearance?
Mini-OSTEO Pedicle Fixation System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K231443.
Who is the listed applicant for Mini-OSTEO Pedicle Fixation System?
The FDA 510(k) record lists Osteomed Indústria E Comércio DE Implantes Ltda as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mini-OSTEO Pedicle Fixation System?
The FDA product code for Mini-OSTEO Pedicle Fixation System is NKB.
相關臨床試驗
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相關器械（代碼：NKB）
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
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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