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

    VERITAS COLLAGEN MATRIX

    K Number: K030879 · Decision Apr 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    35

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    Basic Information

    Device Name
    VERITAS COLLAGEN MATRIX
    K Number
    K030879
    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
    March 20, 2003
    Decision Date
    April 24, 2003
    Product Code
    OXE
    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
    OXE Mesh, Surgical, Collagen, Staple Line Reinforcement

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    Other Clearances by Synovis Surgical Innovations

    K Number Device Name
    K122306 SYNOVIS COLLAGEN MATRIX (TBD)
    K083039 VERITAS COLLAGEN MATRIX (DRY)
    K062915 VERITAS COLLAGEN MATRIX
    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