BEUDAMED
    Product Code: KDA FDA class 2 21 CFR 878.3500

    Prosthesis, Ptfe/Carbon-Fiber

    General, Plastic Surgery

    A PTFE/carbon-fiber prosthesis is a surgically implanted synthetic material device used in soft tissue or reconstructive surgery, made from polytetrafluoroethylene (PTFE) and carbon fiber, offering structural support and biocompatibility for applications such as tendon replacement or augmentation. It is classified as an FDA Class 2 device, representing moderate risk, and requires 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. Product code KDA is regulated under 21 CFR 878.3500 in the General, Plastic Surgery medical specialty. This device is flagged as an implant, indicating it is intended to be placed inside the body.

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

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    Basic Information

    Product Code
    KDA
    Device Class
    FDA class 2
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K861806 MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)