BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Ortho Solutions UK Limited

    Reg #: 3008951116 · FEI: 3008951116 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    48
    Establishment Types
    4
    Classifications
    17

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    Registration Details

    Registration Name
    Ortho Solutions UK Limited
    Registration Number
    3008951116
    FEI Number
    3008951116
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    West Station Business Park, Spital Road
    City
    Maldon Essex
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K121575

    Owner / Operator

    Firm Name
    Ortho Solutions UK Ltd
    Operator Number
    10035321
    Address
    West Station Buisness Park, Spital Road
    City
    Maldon
    State
    Essex
    Postal Code
    CM96FF
    Country
    GB
    Correspondent
    Jesin Synthee

    US Agent

    Business Name
    Ortho Solutions Inc
    Contact Name
    Kevin Brothen
    Address
    209 10th Ave S Ste 416
    City
    Nashville
    State
    TN
    ZIP
    37203
    Country
    US
    Email
    [email protected]
    Phone
    480 5400108

    Products

    Device Name Product Code
    Rod, Fixation, Intramedullary And Accessories HSB
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Bit, Drill HTW
    Staple, Fixation, Bone JDR
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthopedic Manual Surgical Instrument LXH
    Tray, Surgical, Instrument FSM
    Pin, Fixation, Smooth HTY
    Pin, Fixation, Threaded JDW
    Cerclage, Fixation JDQ
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Bur, Surgical, General & Plastic Surgery GFF
    Blade, Saw, General & Plastic Surgery, Surgical GFA

    Proprietary Names

    Oxford Ankle Fusion Nail (AFN) System Oxbridge Ankle Fusion Nail (AFN) System System 26 Headless Compression Cannulated Screws Twist-Off Screws System 26 Headed Compression Cannulated Screws System 26 Washer System Bone Plate/Screw/Washer - Mini Fragment (MFS) Bone Plate/Screw/Washer - Small Fragment (SFS) Systems Bone Plate/Screw/Washer - Large Fragment (LFS) CHS/SCS Compression Plate Cognition Staples Reamers Drill Bit Burr Saw Blade Reamer Ortho Solutions manual surgical instrument Volition Plating System Staples Compression Screw TwistFix Snap-Off Screws Memo Staple Foot Plating (FPS) Meta Screw Foot Osteotomy (FOS) Extremity Fixation (EFS) Surgical Trays Nailing Rods ACL/PCL Passing Pins Fixation Pins Nailing Guide Pins Guide Pins Schanz Screws Rush Pins Steinman Pins - Smooth, Threaded & Calibrated K-Wires - Smooth & Threaded Flexible Guide Wires Cannulated Bone Screw Systems Mini Hoffman Pins Denham Pins Cerclage Wire Sterile Saw Blades Sterile Countersinks Sterile Burrs Sterile Gigli Saws Sterile Drill Bits Sterile Taps

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device