BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ortho Solutions Inc

    Reg #: 3009812190 · FEI: 3022270316 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    Ortho Solutions Inc
    Registration Number
    3009812190
    FEI Number
    3022270316
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    209 10th Avenue S, Ste. 416
    City
    Nashville
    State
    TN
    ZIP
    37203
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250622

    Owner / Operator

    Firm Name
    ORTHO SOLUTIONS INC
    Operator Number
    10042129
    Address
    Ortho Solutions, Unit 5, West Station Business Park, Spital Road
    City
    MALDON
    State
    Essex
    Postal Code
    CM9 6FF
    Country
    GB

    Products

    Device Name Product Code
    Rod, Fixation, Intramedullary And Accessories HSB
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Staple, Fixation, Bone JDR
    Bur, Surgical, General & Plastic Surgery GFF
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Blade, Saw, General & Plastic Surgery, Surgical GFA

    Proprietary Names

    Succession AFN System ORTHO SOLUTIONS PLATING SYSTEM (Voliton Ankle Fracture) ORTHO SOLUTIONS COGNiTiON STAPLE SYSTEM ORTHO SOLUTIONS OXFORD ANKLE FUSION NAIL SYSTEM Volition Plating System ORTHO SOLUTIONS STERILE DRILL BITS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198