BEUDAMED
    Product Code: MRY FDA class 2 21 CFR 888.3040

    Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component

    Orthopedic

    The Absorbable Single/Multiple Component Bone Fixation Appliances and Accessories are orthopedic implants including screws, plates, pins, and anchors made from absorbable materials used to fix bone fractures or fragments, with the implant being gradually resorbed by the body over time. Classified as FDA Class 2 under 21 CFR 888.3040 in the Orthopedic specialty, they require 510(k) premarket notification. The product code is MRY, and these devices carry an implant flag.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MRY
    Device Class
    FDA class 2
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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