BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carolina Precision Technologies

    Reg #: 3010120194 · FEI: 3010120194 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Carolina Precision Technologies
    Registration Number
    3010120194
    FEI Number
    3010120194
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    309 Camars Dr
    City
    Warminster
    State
    PA
    ZIP
    18974
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113395

    Owner / Operator

    Firm Name
    Carolina Precision Technologies, LLC
    Operator Number
    10062074
    Address
    309 Camars Drive
    City
    Warminster
    State
    PA
    Postal Code
    18974
    Country
    US
    Correspondent
    Andrea Gillespie

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)