BEUDAMED
    Product Code: LPF FDA class 3

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

    Unknown

    This device is a semi-constrained hip prosthesis with metal and ceramic-on-ceramic bearing surfaces, intended for cemented fixation, used in total hip arthroplasty to replace a diseased or damaged hip joint. It is classified as a Class 3 (highest risk) device, requiring Premarket Approval (PMA) from the FDA, reflecting the significant clinical consequences of implant failure in a load-bearing joint. The product code is LPF; no regulation number or specific medical specialty code is on file for this entry. This device carries the implant flag, as it is surgically placed permanently within the body.

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

    Basic Information

    Product Code
    LPF
    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

    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.