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

    CONSTRUX Mini PTC Spacer System

    K Number: K202666 · Decision Oct 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    57
    Review Days
    30

    Basic Information

    Device Name
    CONSTRUX Mini PTC Spacer System
    K Number
    K202666
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthofix, Inc.
    Date Received
    September 14, 2020
    Decision Date
    October 14, 2020
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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    Other Clearances by Orthofix, Inc.

    K Number Device Name
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    K210667 FIREBIRD SI Fusion System
    K203342 CONSTRUX Mini Ti Spacer System
    K203576 FORZA Ti Spacer System
    K203138 FIREBIRD SI Fusion System
    K202949 CONSTRUX Mini PEEK Spacer System
    K201664 FIREBIRD SI Fusion System
    K201481 Centurion POCT System
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