BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C&A Tool Engineering, Inc. Auburn Plant

    Reg #: 3014252644 · FEI: 3014252644 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    59
    Establishment Types
    2
    Classifications
    32

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    Registration Details

    Registration Name
    C&A Tool Engineering, Inc. Auburn Plant
    Registration Number
    3014252644
    FEI Number
    3014252644
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1015 W 15th St
    City
    Auburn
    State
    IN
    ZIP
    46706
    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Growing Rod System PGM
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Instrument, Cutting, Orthopedic HTZ
    Prosthesis, Intervertebral Disc MJO
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Orthosis, Spinal Pedicle Fixation MNI
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Pin, Fixation, Smooth HTY
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Bone Cement, Antibiotic MBB
    Bone Fixation Cerclage, Sublaminar OWI
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Instrument, Manual, Surgical, General Use MDM
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Extractor HWB
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    PERIMETER® Interbody Fusion Device SHILLA™ Growth Guidance System ANTERALIGN™ Spinal System with Titan nanoLOCK™ Surface Technology ELEOS Limb Salvage System with BioGrip INFINITY™ Navigated OCT System CD HORIZON® Spinal System 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 PRESTIGE® Cervical Disc System T2 ALTITUDE™ Expandable Corpectomy System CD HORIZON® SOLERA® VOYAGER™ Spinal System BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION T2 STRATOSPHERE™ Expandable Corpectomy System POWEREASE™ Instruments CD Horizon™ Spinal System orthopedic manual surgical instrument PROSTALAC EXCEL StageOne™ Select Hip Neck Length Adapter -6mm StageOne™ Select Hip Neck Length Adapter Standard Size StageOne™ Select Hip Neck Length Adapter +6mm instrument, manual, surgical, general use Echo FX RIALTO™ SI FUSION SYSTEM ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology ARTiC-L™ Spinal System FREEDOM CONSTRAINED LINERS 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 VERTEX® Reconstruction System CD Horizon™ ModuLeX™ Spinal System CD Horizon(TM) Spinal System CD Horizon® Ballast™ Spinal System

    Establishment Types

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