BEUDAMED
    Product Code: KRQ FDA class 2 21 CFR 888.3550

    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer

    Orthopedic

    This device is a constrained cemented patello-femorotibial knee prosthesis made from polymer, metal, and polymer components, used in total knee arthroplasty where full constraint of the femorotibial and patellofemoral joints is required. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRQ, regulated under 21 CFR 888.3550 within the Orthopedic specialty. This device is designated as an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KRQ
    Device Class
    FDA class 2
    Regulation Number
    888.3550
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.