BEUDAMED
    Product Code: PIX FDA not classified

    Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis

    Unknown

    The Elbow Joint Metal/Polymer Constrained Porous Coated Uncemented Prosthesis is an orthopedic implant intended to replace the elbow joint using a constrained, porous-coated design that achieves fixation without bone cement. It is classified as "Not Classified" (Class N) by the FDA, requiring further classification determination, reviewed by the Orthopedic (OR) panel. The product code is PIX, and it is flagged as an implant. No regulation number or medical specialty has been formally assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PIX
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    3

    Device Characteristics

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

    Definition

    An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.