BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROTEOR USA, Gunnison

    Reg #: 3004737223 · FEI: 3004737223 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    56
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    PROTEOR USA, Gunnison
    Registration Number
    3004737223
    FEI Number
    3004737223
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    491 East 350 North
    City
    Gunnison
    State
    UT
    ZIP
    84634
    Country
    US

    Owner / Operator

    Firm Name
    PROTEOR USA
    Operator Number
    10032353
    Address
    1236 West Southern Avenue, Suite 101
    City
    Tempe
    State
    AZ
    Postal Code
    85282
    Country
    US
    Correspondent
    Valery Barbour

    Products

    Device Name Product Code
    Component, External, Limb, Ankle/Foot ISH
    Assembly, Knee/Shank/Ankle/Foot, External ISW
    Valve, Prosthesis ISP
    Bandage, Cast ITG
    Joint, Ankle, External Brace ITW
    Joint, Knee, External Limb Component ISY
    Prosthesis, Thigh Socket, External Component ISS

    Proprietary Names

    Easy Run Blade SACH Foot Gery Foot Highlander Foot,FS3 PLIE 3 Knee, KD3 & KS3 Kinnex Ankle/Foot,F14 RUSH Kid Foot ACCESSORIES DynaTrek Ethos LP foot MALLEOLAR JUNCTION PLATE Sierra Foot,FS1 MULTIAXIS ANKLE SHAPED FOAM ANKLE RUSH HiPro; RUSH HiProEVAQ8; RUSH HiProH2O Feet Foot Covering with Faiting (Cap) Interface, FTF Agilix Foot,F15 Pacifica Foot,FS2 Foot Covering without Fairing (Cap) Interface, FTC RUSH Chopart Foot Single Axis Foot RUSH RAMPAGE; RUSH RAMPAGE EVAQ8; RUSH RAMPAGE LP; RUSH RAMPAGE LP H2O Feet RUSH ROGUE2; ROGUE2 EVAQ8; ROGUE2 H2O Feet DynaStep Foot Shockwave Foot Kinterra Foot/Ankle, RM3 DynAdapt Foot,F10 RUSH ROVER Foot Pacifica LP Foot,FS4, SYNSYS Leg Valve Pad bandage Cover for buckle Bandage Aflex ANKLE PRONG CONNECTOR AND DISH FOAM COVERING 4-AXIS KNEE Easy Ride BASE TUBE Trans-Femoral Rotator HyTrek THREAD CONNECTION ADAPTOR DISTAL LOCKING Proteor Quattro Microprocessor Knee SINGLE AXIS KNEE W/BRAKE FEMALE PYRAMID CONNECTOR Hydeal Knee CONNECTION ADAPTOR Matik Knee LOCKING KNEE COMPACT 4-AXIS KNEE KEASY Stepline ADJUS TEMPORARY SOCKET Silitouch

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198