BEUDAMED
    Product Code: PNW FDA class 3

    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

    Unknown

    The Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant (product code PNW) is a Class 3 device that is implanted in the metatarsal head of the first metatarsophalangeal joint as a cartilage replacement. Class 3 devices require Premarket Approval (PMA). The device is flagged as an implant and has no assigned regulation number or formal medical specialty designation.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PNW
    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

    The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.