BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optossol Compression Device System

    Reg #: 3014522470 · FEI: 3014522470 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MAXXHEALTH
    Registration Number
    3014522470
    FEI Number
    3014522470
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11 Woodside Ave
    City
    Berwyn
    State
    PA
    ZIP
    19312
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140875

    Owner / Operator

    Firm Name
    MaxxHealth
    Operator Number
    10057283
    Address
    11 Woodside Ave
    City
    Berwyn
    State
    PA
    Postal Code
    19312
    Country
    US
    Correspondent
    Edward Cahill

    Products

    Device Name Product Code
    Pin, Fixation, Threaded JDW
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN

    Proprietary Names

    Optossol Compression Device System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198