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

    SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

    K Number: K041961 · Decision Oct 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
    K Number
    K041961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scandius Biomedical, Inc.
    Date Received
    July 21, 2004
    Decision Date
    October 20, 2004
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Scandius Biomedical, Inc.

    K Number Device Name
    K063499 MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
    K063497 MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
    K060522 SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
    K052810 SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
    K041749 SCANDIUS ACL RECONSTRUCTION SYSTEM