BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Geminus XL

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

    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
    K182492

    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

    Proprietary Names

    Geminus XL

    Establishment Types

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