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510(k) Data Aggregation

    K Number
    K170482
    Device Name
    Spider Frame External Fixation System
    Manufacturer
    TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
    Date Cleared
    2017-09-27

    (223 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones. Indications are: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion 2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 3. Open and closed fracture fixation 4. Pseudoarthrosis of long bones 5. Limb lengthening by epiphyseal or metaphyseal distraction 6. Correction of bony or soft tissue deformities 7. Correction of segmental bony or soft tissue defects 8. Joint arthrodesis 9. Infected fractures or nonunions,
    Device Description
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