可吸收頭蓋骨瓣固定系統
K 號：K221606 · 2023-11-21
廣告
決定日期2023-11-21
產品代碼GXR
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
決定相當於
器材摘要
Absorbable Cranial Flap Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Chendu Medart Medical Scientific Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K221606. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Absorbable Cranial Flap Fixation System?
Absorbable Cranial Flap Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Chendu Medart Medical Scientific Co., Ltd.. The 510(k) number is K221606.
When did Absorbable Cranial Flap Fixation System receive FDA 510(k) clearance?
Absorbable Cranial Flap Fixation System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K221606.
Who is the listed applicant for Absorbable Cranial Flap Fixation System?
The FDA 510(k) record lists Chendu Medart Medical Scientific Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Absorbable Cranial Flap Fixation System?
The FDA product code for Absorbable Cranial Flap Fixation System is GXR.
相關臨床試驗
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相關器械（代碼：GXR）
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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