BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Highridge Medical, LLC

    Reg #: 3012447612 · FEI: 3012447612 · Expires 2026
    View on FDA
    Products
    112
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    112

    Registration Details

    Registration Name
    Highridge Medical, LLC
    Registration Number
    3012447612
    FEI Number
    3012447612
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10225 Westmoor Dr
    City
    Westminster
    State
    CO
    ZIP
    80021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132894
    PMA Number
    H190005

    Owner / Operator

    Firm Name
    Highridge Medical, LLC
    Operator Number
    9061535
    Address
    10225 Westmoor Dr.
    City
    Westminster
    State
    CO
    Postal Code
    80021
    Country
    US
    Correspondent
    Alex - Pawlowski

    Products

    Device Name Product Code
    Motor, Surgical Instrument, Ac-Powered GEY
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Vertebral Body Tethering System QHP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Prosthesis, Intervertebral Disc MJO
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Thoracolumbosacral Pedicle Screw System NKB
    Bit, Drill HTW
    Endoscope, Neurological GWG
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Passer, Wire, Orthopedic HXI
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Guide, Needle, Surgical GDF
    Catheter And Tip, Suction JOL
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Arthroscope HRX
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Elevator HTE
    System, Facet Screw Spinal Device MRW
    Instrument, Surgical, Non-Powered HAO
    Forceps HTD
    Tape, Measuring, Rulers And Calipers FTY
    Driver, Surgical, Pin GFC
    Stimulator, Invasive Bone Growth LOE
    Tap, Bone HWX
    Posterior Cervical Screw System NKG
    Clamp HXD
    Countersink HWW
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Extractor HWB
    Wrench HXC
    Trephine HWK
    Spatula, Orthopedic HXR
    Tray, Surgical LRP
    Starter, Bone Screw HWD
    Wire, Fixation, Intraosseous DZK
    Mallet HXL
    Filler, Bone Void, Calcium Compound MQV
    Caliper KTZ
    Osteotome HWM
    Cutter, Surgical FZT
    Cerclage, Fixation JDQ
    Rasp HTR
    Orthopedic Manual Surgical Instrument LXH
    Orthopedic Stereotaxic Instrument OLO
    Handle, Scalpel GDZ
    Light, Surgical, Fiberoptic FST
    Punch, Surgical LRY
    Rasp, Surgical, General & Plastic Surgery GAC
    Curette HTF
    Neurological Stereotaxic Instrument HAW
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Bender HXW
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Growing Rod System PGM
    Reamer HTO
    Single Use Instrument Tray OJV
    Bone Grafting Material, Synthetic LYC
    Cutter, Wire HXZ
    Dissector, Surgical, General & Plastic Surgery GDI
    Tray, Surgical, Instrument FSM
    Table And Attachments, Operating-Room BWN
    Instrument, Bending Or Contouring HXP
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Awl HWJ
    Guide, Surgical, Instrument FZX
    Instrument, Biopsy KNW
    Dispenser, Cement KIH
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Methyl Methacrylate For Cranioplasty GXP
    Osteotome, Manual GFI
    Hammer, Surgical FZY
    Stimulator, Bone Growth, Non-Invasive LOF
    Instrument, Cutting, Orthopedic HTZ
    Bone Fixation Cerclage, Sublaminar OWI
    Rongeur HTX
    Hook, Surgical, General & Plastic Surgery GDG
    Cannula, Surgical, General & Plastic Surgery GEA
    Twister, Wire HXS
    Retainer, Surgical GCZ
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Instrument, Compression HWN
    Impactor HWA
    Forceps, General & Plastic Surgery GEN
    Filters, Cell Collection, Tissue Processing KET
    Clamp, Surgical, General & Plastic Surgery GDJ
    Screwdriver HXX
    Pliers, Surgical HTC
    Probe HXB
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Hook, Bone KIK
    File, Surgical, General & Plastic Surgery GEO
    Filler, Bone Void, Non-Osteoinduction MBS
    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation OIS
    Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses LMN
    Spinous Process Plate PEK
    Goniometer, Nonpowered KQW
    Manual Instruments Designed For Use With Total Disc Replacement Devices QLQ
    Electrosurgical Electrode Kit NWI
    Retractor, Fiberoptic FDG
    Saw, Powered, And Accessories HAB
    Tamp HXG
    Chisel, Surgical, Manual FZO
    Gauge, Depth HTJ
    Template HWT
    Retractor GAD

    Proprietary Names

    Vital Spinal Fixation System Passer, Wire, Orthopedic FlareHawk Interbody Fusion System FlareHawk LineSider Spinal System Virage® OCT Spinal Fixation System Clamp bipolar forceps TM-400 Surgical Tray Vista-S Integrity Implants Navigated Instruments FlareHawk11/TiHawk11 Toro-L Interbody Fusion System HD Lumbar Interbody System Vital Navigation Vitality® Spinal Fixation System Hive™ Stand-alone Anterior Lumbar Interbody System Virage Navigation Chisel

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device