BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PUP- Internal Joint Stabilizer- Elbow

    Reg #: 3006742481 · FEI: 3006742481 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    SKELETAL DYNAMICS, INC
    Registration Number
    3006742481
    FEI Number
    3006742481
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7300 N Kendall Drive, Suite 800
    City
    Miami
    State
    FL
    ZIP
    33156
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223318

    Owner / Operator

    Firm Name
    Skeletal Dynamics, Inc
    Operator Number
    10034431
    Address
    7300 N Kendall Drive, Suite 800
    City
    Miami
    State
    FL
    Postal Code
    33156
    Country
    US
    Correspondent
    Mario A Arbesu

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Internal Hinged Elbow Fixator OZI
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT

    Proprietary Names

    PUP- Internal Joint Stabilizer- Elbow

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198