BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C+A TOOL ENGINEERING, INC.

    Reg #: 1836357 · FEI: 3003064967 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    82
    Establishment Types
    2
    Classifications
    53

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    Registration Details

    Registration Name
    C+A TOOL ENGINEERING, INC.
    Registration Number
    1836357
    FEI Number
    3003064967
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4100 N. US 33
    City
    Churubusco
    State
    IN
    ZIP
    46723
    Country
    US

    Owner / Operator

    Firm Name
    MinebeaMitsumi Inc.
    Operator Number
    10055758
    Address
    3-9-6 Mita
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    108-8330
    Country
    JP

    Products

    Device Name Product Code
    Accessories, Arthroscopic NBH
    Bit, Drill HTW
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    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, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthopedic Stereotaxic Instrument OLO
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Guide, Surgical, Instrument FZX
    Instrument, Cutting, Orthopedic HTZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Pin, Fixation, Smooth HTY
    Bone Mill LYS
    Plate, Fixation, Bone HRS
    Screwdriver HXX
    Awl HWJ
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Manual Surgical Instrument LXH
    Rasp HTR
    Tamp HXG
    Syringe, Piston FMF
    Extractor HWB
    Impactor HWA
    Punch, Femoral Neck HWP
    Bone Cement, Antibiotic MBB
    Instrument, Manual, Surgical, General Use MDM
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX
    Gauge, Depth HTJ
    Spinal Vertebral Body Replacement Device MQP
    Driver, Prosthesis HWR
    Retractor GAD
    Tap, Bone HWX
    Neurological Stereotaxic Instrument HAW
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Broach HTQ
    Instrument, Bending Or Contouring HXP
    Reamer HTO
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Bone Fixation Cerclage, Sublaminar OWI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Template HWT
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    accessories,arthroscopic bit, drill ZMR Hip System CD HORIZON® SOLERA® VOYAGER™ Spinal System MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA ELEOS Limb Salvage System with BioGrip guide, surgical, instrument NEXGEN ANTERIOR FEMORAL CUTTING GUIDE NEXGEN INTRAMEDULLARY INSTRUMENTS Glenoid SIGMA SP1*DIS F CT BK SLOT 9MM SPAC SP2*DIS F CT BK SLOT 9MM SPAC SP2*DIS F CT BK NSLT 10MM SPAC pin, fixation, smooth WIRE & STEINMAN PINS bone mill screwdriver CD Horizon™ ModuLeX™ Spinal System CD Horizon(TM) Spinal System orthopedic manual surgical instrument PROSTALAC EXCEL CD HORIZON® Spinal System Soft Graft Tamp; Wire Tamp PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM ANTERALIGN™ Spinal System with Titan nanoLOCK™ Surface Technology extractor SP2FEMNTCHGD BSH13MM5DG+2R/-2L SP*2 F NOT GD BH,13M/7D 0 OFFS SP*2 F NOT GD BUS IM/5D 0 OFFS SPEC2*TB CE ST PUN1.5-3SZ13X60 SP*2 F NOT GD BUS IM/7D 0 OFFS SP2FEMNTCHGD BSH15MM5DG+2L/-2R SP2FEM NTCH GDBUSHIM5DG+2R/-2L SP2FEM NTCH GDBUSHIM7DG+2L/-2R SP2FEMNTCHGD BSH13MM5DG+2L/-2R SP2FEM NTCH GDBUSHIM7DG+2R/-2L SP*2 TB CE STM PUN/SZ4-6/15X30 SP2FEMNTCHGD BSH13MM7DG+2L/-2R SP*2 TB CE STM PUN/SZ4-6/15X60 SP*2 F NOT GD BH,15M/7D 0 OFFS SP*2 F NOT GD BH,13M/5D 0 OFFS SP2FEMNTCHGD BSH15MM5DG+2R/-2L SP2FEMNTCHGD BSH15MM7DG+2R/-2L SP2FEMNTCHGD BSH13MM7DG+2R/-2L SPEC2*TB CE ST PUN1.5-3SZ13X30 SP2*DIS F CT BK SLOT 11MM SPAC SP2FEM NTCH GDBUSHIM5DG+2L/-2R PFC STEM TRIAL EXTRACT SP*2 F NOT GD BH,15M/5D 0 OFFS SP2FEMNTCHGD BSH15MM7DG+2L/-2R Impactor Biomet Impactor Vanguard ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology ARTiC-L™ Spinal System instrument, manual, surgical, general use Echo FX Gauge, Depth T2 ALTITUDE™ Expandable Corpectomy System VERTEX® Reconstruction System FREEDOM CONSTRAINED LINERS S-ROM driver, prosthesis SUMMIT Retractor BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS POWEREASE™ Instruments RIALTO™ SI FUSION SYSTEM StageOne™ Select Hip Neck Length Adapter -6mm StageOne™ Select Hip Neck Length Adapter Standard Size StageOne™ Select Hip Neck Length Adapter +6mm Broach reamer INFINITY™ Navigated OCT System BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION CD Horizon™ Spinal System Template LCS CD Horizon® Ballast™ Spinal System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only