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

    ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY

    K Number: K043260 · Decision Aug 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    261

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    Basic Information

    Device Name
    ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
    K Number
    K043260
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthocon, LLC
    Date Received
    November 24, 2004
    Decision Date
    August 12, 2005
    Product Code
    MTJ
    Advisory Committee
    Unknown
    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
    MTJ Wax, Bone

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    Other Clearances by Orthocon, LLC

    K Number Device Name
    K142339 HEMASORB Resorbable Hemostatic Bone Putty