ZipE 齐邊無縫組織修復及附著設備
K 號：K162429 · 2017-03-13
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器材摘要
ZipE Knotless Tissue Repair and Attachment Devices is the device name listed in this FDA 510(k) record. The listed applicant is Ziptek, LLC. It received FDA 510(k) clearance on 2017-03-13 under 510(k) number K162429. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ZipE Knotless Tissue Repair and Attachment Devices?
ZipE Knotless Tissue Repair and Attachment Devices is a medical device that received FDA 510(k) clearance on 2017-03-13. The listed applicant is Ziptek, LLC. The 510(k) number is K162429.
When did ZipE Knotless Tissue Repair and Attachment Devices receive FDA 510(k) clearance?
ZipE Knotless Tissue Repair and Attachment Devices received FDA 510(k) clearance on 2017-03-13, under 510(k) number K162429.
Who is the listed applicant for ZipE Knotless Tissue Repair and Attachment Devices?
The FDA 510(k) record lists Ziptek, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZipE Knotless Tissue Repair and Attachment Devices?
The FDA product code for ZipE Knotless Tissue Repair and Attachment Devices is MAI.
相關臨床試驗
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相關器械（代碼：MAI）
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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