彈性縫合系統帶有釘針（FSSA）
K 號：K222589 · 2023-01-26
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器材摘要
Flexible Suturing System with Anchors (FSSA) is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K222589. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Flexible Suturing System with Anchors (FSSA)?
Flexible Suturing System with Anchors (FSSA) is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Integrity Orthopaedics, Inc.. The 510(k) number is K222589.
When did Flexible Suturing System with Anchors (FSSA) receive FDA 510(k) clearance?
Flexible Suturing System with Anchors (FSSA) received FDA 510(k) clearance on 2023-01-26, under 510(k) number K222589.
Who is the listed applicant for Flexible Suturing System with Anchors (FSSA)?
The FDA 510(k) record lists Integrity Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flexible Suturing System with Anchors (FSSA)?
The FDA product code for Flexible Suturing System with Anchors (FSSA) is MBI.
相關臨床試驗
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相關器械（代碼：MBI）
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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