BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Signature Orthopaedics Europe Ltd

    Reg #: 3014763043 · FEI: 3014763043 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    99
    Establishment Types
    3
    Classifications
    30

    Registration Details

    Registration Name
    Signature Orthopaedics Europe Ltd
    Registration Number
    3014763043
    FEI Number
    3014763043
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit A, IDA Business & Technology Park, Garrycastle
    City
    Athlone Westmeath
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K240683

    Owner / Operator

    Firm Name
    Signature Orthopaedics Pty Limited
    Operator Number
    10037793
    Address
    7 Sirius Road
    City
    Lane Cove West
    State
    New South Wales
    Postal Code
    2066
    Country
    AU
    Correspondent
    Declan P Brazil

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Posterior Cervical Screw System NKG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Tape, Measuring, Rulers And Calipers FTY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Impactor HWA
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Screw, Fixation, Bone HWC
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Retractor GAD
    Osteotome HWM
    Driver, Prosthesis HWR
    Tray, Surgical, Instrument FSM
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN
    Hammer, Surgical FZY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    Rx Knee System Fusion Taper System Evolve AP Cup Shoulder Anchors Longboard Stem BiPolar Head Femoral Head Freedom Posterior Cervical Screw Evolve Helios Stem Pelion Stem Pegasus Stem Bipolar Head Remedy Stem Evolve Masters Stem Distal Centraliser Cement Plug SKYLON Stem Encina Taper A Active-V Knee Patella Caliper TriVerse Knee BIOLOX Forte Encina HA Femoral Stem Standard Offset Collared Manza Polyethylene Liner Manza Screws Logical Acetabular Liner Logical G Series Cup Apex Hole Cover BIOLOX Delta Aria Stem Encina HA Femoral Stem Standard Offset NEO-T Stem Tryon Liner Encina Taper Femoral Stem High Offset Encina HA Femoral Stem High Offset CoCr Head Manza Hole Cover Logical Bone Screw Kratos Stem Manza Heads Encina Taper Femoral Stem Standard Offset Logical PX Series Logical Hole Cover Origin Stem Tryon Acetabular Cup Fixation Screw Sirocco Stem Stratus Stem Vento Cup Vento Fixation Screw Cancellous Bone Screw Ceramic Head Vento XLPE Liner Logical XLPE Liner World Total Knee System World Knee Liner Impactor World Hip System Origin TT Active-X Cemented Femoral Component Active-X Inlay Patella Component Active-X Regular Meniscal Insert Active-X Patella Component Active-X Cemented Tibial Component Active-X Ultracongruent+ Meniscal Insert Active-X Ultracongruent Meniscal Insert SignaLoc Screw PEEK RCI Screw Biocomposite Screw Verteloc Spinal System Dymaxeon Spine System SignaSure Dual Mobility System Spartan Genius Total Knee System PureGenius Total Knee System Genius Total Knee Trial Instruments Crescendo Total Knee System Logical 20deg Hooded Liner Logical Constrained Liner Manza Shell Logical C-Series Shell Logical Lateralised Liner Retractor Origin Lateral Offset Collared Hip Stem Origin Coxa Vara Stem Origin Short Neck ENCINA HA Femoral Stem Coxa Vara STRATUS Stem TriVerse I-Beam Osteotome TriVerse Fin Punch TriVerse I-Beam Solid Punch DM Sleeve Driver TriVerse Tray Everglade Hip Stem Xerxes Hip Stem Osteosynthesis Plate System Slap Hammer World Hip Cambridge Partial Knee

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)