BEUDAMED
    Product Code: SGK FDA class 3

    Prosthesis, Spinous Process Tension Band Implant

    Unknown
    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    SGK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.