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

    VERITAS COLLAGEN MATRIX

    K Number: K062915 · Decision Dec 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    VERITAS COLLAGEN MATRIX
    K Number
    K062915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synovis Surgical Innovations
    Date Received
    September 27, 2006
    Decision Date
    December 6, 2006
    Product Code
    FTM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTM Mesh, Surgical

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    Other Clearances by Synovis Surgical Innovations

    K Number Device Name
    K122306 SYNOVIS COLLAGEN MATRIX (TBD)
    K083039 VERITAS COLLAGEN MATRIX (DRY)
    K041669 VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
    K040415 PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
    K040119 PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
    K040001 STEERABLE STYLET
    K030879 VERITAS COLLAGEN MATRIX