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510(k) Data Aggregation

    K Number
    K171357
    Device Name
    SurgiMend PRS Meshed, Revize-X
    Manufacturer
    Integra LifeSciences Corporation (Owner of TEI Biosciences)
    Date Cleared
    2017-06-07

    (29 days)

    Product Code
    OXH, FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Integra LifeSciences Corporation (Owner of TEI Biosciences)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.
    Device Description
    SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.
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