BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CULVER TOOL & ENGINEERING

    Reg #: 3010047454 · FEI: 3010047454 · Expires 2026
    View on FDA
    Products
    64
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    64

    Registration Details

    Registration Name
    CULVER TOOL & ENGINEERING
    Registration Number
    3010047454
    FEI Number
    3010047454
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1901 Walter Glaub Dr, 2121 Walter Glaub Dr
    City
    Plymouth
    State
    IN
    ZIP
    46563
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171448

    Owner / Operator

    Firm Name
    Culver Tool & Engineering LLC dba SpiTrex CTE
    Operator Number
    10043008
    Address
    2121 Walter Glaub Dr
    City
    Plymouth
    State
    IN
    Postal Code
    46563
    Country
    US
    Correspondent
    Heather R Houin

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Rod, Fixation, Intramedullary And Accessories HSB
    Spinal Vertebral Body Replacement Device MQP
    Posterior Cervical Screw System NKG
    Tap, Bone HWX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Orthopedic Manual Surgical Instrument LXH
    Washer, Bolt Nut HTN
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    System, Facet Screw Spinal Device MRW
    Orthopedic Stereotaxic Instrument OLO
    Template HWT
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Growing Rod System- Magnetic Actuation PGN
    Orthopedic Augmented Reality SBF
    Reamer HTO
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Growing Rod System PGM
    Probe HXB
    Device, Germicidal, Ultraviolet MKB
    Instrument, Manual, Surgical, General Use MDM
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Wrench HXC
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Stimulator, Nerve ETN
    Neurological Stereotaxic Instrument HAW
    Neurosurgical Nerve Locator PDQ
    Stimulator, Electrical, Evoked Response GWF
    Electromyograph, Diagnostic IKN
    Rongeur HTX
    Tray, Surgical, Instrument FSM
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Starter, Bone Screw HWD
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Tamp HXG
    Hammer, Surgical FZY
    Screwdriver HXX
    Continuous Measurement Thermometer FLL
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Catheter, Continuous Flush KRA
    Retractor GAD
    Passer HWQ
    Punch, Femoral Neck HWP
    Sacroiliac Joint Fixation OUR
    Awl HWJ
    Rasp HTR
    Bit, Drill HTW
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    proprietary Globus Medical-Creo DLX Deformity Stabilization System Harrier - SA Orthopediatrics PediNail Intramedullary Platform Globus Medical gibralt Proprietary Ferris Smith Pitutiary Rongeur PROPRIETARY NAV-M InCompass (Spinal Fixation System) Pre-Bent Support Rod 5.5mm Rod x _____mm Polaris Gibralt Proliant Nautilus (CoCr) Orthopediatrics Response 5.5/6 Spine System Nanovis Technology Proprietary Name Alphatec Orthopediatrics - Blade Plate System Navigation LLIF AMP Laminoplasty

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device