BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HARWOOD DESIGN, INC.

    Reg #: 3003761012 · FEI: 3003761012 · Expires 2026
    View on FDA
    Products
    74
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    74

    Registration Details

    Registration Name
    HARWOOD DESIGN, INC.
    Registration Number
    3003761012
    FEI Number
    3003761012
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1507 Clyde Waite Drive
    City
    Bristol
    State
    PA
    ZIP
    19007
    Country
    US

    Owner / Operator

    Firm Name
    Harwood Design, Inc.
    Operator Number
    10043110
    Address
    1507 Clyde Waite Drive
    City
    Bristol
    State
    PA
    Postal Code
    19007
    Country
    US
    Correspondent
    Adam Cilli

    Products

    Device Name Product Code
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthopedic Stereotaxic Instrument OLO
    Neurological Stereotaxic Instrument HAW
    Sacroiliac Joint Fixation OUR
    Bone Cement, Posterior Screw Augmentation PML
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Device, Fixation, Proximal Femoral, Implant JDO
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Posterior Cervical Screw System NKG
    Tube, Tonsil Suction KCB
    Retractor GAD
    Needle, Suturing, Reusable GDL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Nail, Fixation, Bone JDS
    Rod, Fixation, Intramedullary And Accessories HSB
    Prealbumin, Fitc, Antigen, Antiserum, Control DDS
    Instrument, Ligature Passing And Knot Tying HCF
    Needle, Aspiration And Injection, Reusable GDM
    Esophagoscope (Flexible Or Rigid) EOX
    Tape, Measuring, Rulers And Calipers FTY
    Clamp, Vascular DXC
    Growing Rod System PGM
    Retractor, Self-Retaining FFO
    Probe, Ent KAK
    Speculum, Ent EPY
    Laryngoscope, Nasopharyngoscope EQN
    Tray, Surgical, Instrument FSM
    Forceps, Biopsy, Bronchoscope (Rigid) JEK
    Mediastinoscope, Surgical EWY
    Awl HWJ
    Instrument, Ent Manual Surgical LRC
    Source, Carrier, Fiberoptic Light EQH
    Bougie, Esophageal, Ent KCD
    Bone Fixation Cerclage, Sublaminar OWI
    Tube, Ear Suction JZF
    Retractor, Fiberoptic FDG
    Laser, Neodymium:Yag, Pulmonary Surgery LLO
    Tray, Surgical LRP
    Catheter, Irrigation GBX
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    System, Facet Screw Spinal Device MRW
    Retention Device, Suture KGS
    Bronchoscope (Flexible Or Rigid) EOQ
    Cerclage, Fixation JDQ
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Catheter And Tip, Suction JOL
    Tube Tracheostomy And Tube Cuff JOH
    Instruments, Surgical, Cardiovascular DWS
    Laryngoscope, Rigid CCW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Clamp HXD
    Tube, Laryngectomy KAC

    Proprietary Names

    TRIFORE CERVICAL PLATE SYSTEM TRANSOM CERVICAL PLATE SYSTEM LATIS CREO AMP Threaded Stabilization System ExcelsiusFlex Arthroplasty FORTIFY I EXCELSIUS Core Spine Pilling Pilling Laser Bronchoscopes CREO AMP Threaded Deformity Stabilization TRUSS ASSURE BELVEDERE LATERAL PLATING SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)