BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AlphaVent Suture Anchors

    K Number: K231093 · Decision Aug 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    92
    Review Days
    134

    Basic Information

    Device Name
    AlphaVent Suture Anchors
    K Number
    K231093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Endoscopy
    Date Received
    April 18, 2023
    Decision Date
    August 30, 2023
    Product Code
    MBI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Stryker Endoscopy

    K Number Device Name
    K250544 Knotilus+ Biocomposite Knotless Anchor
    K250528 Stryker AlphaVent™ Knotless SP Biocomposite Anchor
    K241401 Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
    K240407 ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
    K240174 1688 4K Camera System with Advanced Imaging Modality
    K233635 SPY Cystoscope/Hysteroscope
    K233893 AlphaVent Knotless SP PEEK Anchor
    K233327 1788 4K Camera System with Advanced Imaging Modality
    K232683 Knotilus+ PEEK Knotless Anchor
    K230886 Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
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