BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mendell

    Reg #: 3009998573 · FEI: 3009998573 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    36

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    Registration Details

    Registration Name
    Mendell
    Registration Number
    3009998573
    FEI Number
    3009998573
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21463 Grenada Ave
    City
    Lakeville
    State
    MN
    ZIP
    55044
    Country
    US

    Owner / Operator

    Firm Name
    Mendell Machine and Manufacturing, LLC
    Operator Number
    10042591
    Address
    21463 Grenada Avenue
    City
    Lakeville
    State
    MN
    Postal Code
    55044
    Country
    US
    Correspondent
    Susan Mayer

    Products

    Device Name Product Code
    Driver, Surgical, Pin GFC
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Screwdriver HXX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Retainer, Surgical GCZ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Instrument, Bending Or Contouring HXP
    Cannula, Surgical, General & Plastic Surgery GEA
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Probe HXB
    Rod, Fixation, Intramedullary And Accessories HSB
    Screw, Fixation, Bone HWC
    Hammer, Surgical FZY
    Sacroiliac Joint Fixation OUR
    Extractor HWB
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Retractor GAD
    Guide, Surgical, Instrument FZX
    System, Facet Screw Spinal Device MRW
    Awl HWJ
    Penile Implant Surgical Accessories QGA
    Template HWT
    Venous Window Needle Guide PFH
    Impactor HWA
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL

    Proprietary Names

    Breckenridge Tomcat Constrained Knee Insert Impactor Aleutian Lateral VariLift LX Affixus Sicage Implant Thunderbolt/Lancer Sizer PrimaLOK SP Sabre Shark Harpoon Hornet

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)