BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    SIGNATURE ORTHOPAEDICS PTY LIMITED

    Reg #: 3008262872 · FEI: 3008262872 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    166
    Establishment Types
    3
    Classifications
    38

    Registration Details

    Registration Name
    SIGNATURE ORTHOPAEDICS PTY LIMITED
    Registration Number
    3008262872
    FEI Number
    3008262872
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7 Sirius Road, Lane Cove West
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K220495

    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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    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
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Retractor GAD
    Hammer, Surgical FZY
    Screw, Fixation, Bone HWC
    Driver, Prosthesis HWR
    Cannula And Trocar, Suprapubic, Non-Disposable FBM
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Tray, Surgical, Instrument FSM
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Posterior Cervical Screw System NKG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN
    Impactor HWA
    Tape, Measuring, Rulers And Calipers FTY
    Osteotome HWM
    Template HWT
    Instrument, Manual, Surgical, General Use MDM
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Bit, Drill HTW
    Orthopedic Manual Surgical Instrument LXH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG

    Proprietary Names

    SignaSure Dual Mobility System Pinehurst Anterior Cervical Plate System Evolve AP Cup Brisbane ALIF Cage Gladstone ALIF Cage Rx Knee System Shoulder Anchors Retractor Genius Total Knee System PureGenius Total Knee System Genius Total Knee Trial Instruments Crescendo Total Knee System 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 Femoral Head 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 Cemented TSI Hip Stem Spartan World Knee Slap Hammer SignaLoc Screw PEEK RCI Screw Biocomposite Screw DM Sleeve Driver Imboki Knee Instrument System The Beeley Trocar Dymaxeon Spine System Evolve Helios Stem Pelion Stem Pegasus Stem Bipolar Head Remedy Stem Evolve Masters Stem Distal Centraliser Cement Plug SKYLON Stem Encina Taper A Xerxes Hip Stem TriVerse Tray World Knee System Freedom Posterior Cervical Screw Fusion Taper System Osteosynthesis Plate System Liner Impactor World Hip System Patella Caliper TriVerse I-Beam Osteotome TriVerse Fin Punch TriVerse I-Beam Solid Punch Trial Devices Everglade Hip Stem Hammers Stylus Currette Chisels Calipers Guides Clamps Cambridge Partial Knee TSI Stem Origin-NS World Total Knee System Cemented Origin Hip Stem Logical 20deg Hooded Liner Logical Constrained Liner Manza Shell Logical C-Series Shell Logical Lateralised Liner Surgibit Optimus Drills Pins IM Drill Tibial Alignment Guide Imboki Instrument Set TSI Starter Rasp Femoral Broach Tapered Hex Driver Liner Inserter Lightning Curved Reamer Handle Calcar Reamer Acetabular Reamer Flexible Driver Bipolar Head Fitting Jig Multi Axial Hex Driver Head Extractor Bipolar Scissors Clutch Screw Driver Reamer Handle Femoral Head Extractor Stem Extractor Bipolar Head Inserter Cup Inserter The Happy Gilmore Femoral Sound Screw Inserter Ratchet Driver X8 Locking Driver Head Impactor Liner Collar Popper Ball Joint Driver Uni Polar Head Inserter T-Handle Trial Inserter Monobloc Hex Driver Screw Forceps Total Hip Instrument Longboard Stem Origin Lateral Offset Collared Hip Stem Origin Coxa Vara Stem Origin Short Neck ENCINA HA Femoral Stem Coxa Vara STRATUS Stem World Knee Total Knee Replacement System Active-V Knee Verteloc Spinal System Arlington PLIF Cage TriVerse Knee C-Zero Pedicle Screw System, Freedom Pedicle Screw System Evolve Unipolar Head Evolve Unipolar Taper Sleeve Manza UniPolar Head BiPolar Head Origin TT Logical Acetabular World Hip NOOSA Anterior Lumbar Plate System NAMBUCCA Anterior Lumbar Plate System CAIRNS Anterior Lumbar Plate System 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

    Establishment Types

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