BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STELLAR Knee

    Reg #: 3025287527 · FEI: 3025287527 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    POLARISAR INC
    Registration Number
    3025287527
    FEI Number
    3025287527
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    78 Sw 7th St Ste 500
    City
    Miami
    State
    FL
    ZIP
    33130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232176

    Owner / Operator

    Firm Name
    PolarisAR Inc
    Operator Number
    10090108
    Address
    78 SW 7th Street, Suite 500
    City
    Miami
    State
    FL
    Postal Code
    33130
    Country
    US
    Correspondent
    Brandon Keirns

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    STELLAR Knee

    Establishment Types

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