BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Viper Prime

    Reg #: 3004464325 · FEI: 3004464325 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DEPUY ORTHOPAEDICS
    Registration Number
    3004464325
    FEI Number
    3004464325
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    50 SCOTLAND BLVD.
    City
    BRIDGEWATER
    State
    MA
    ZIP
    02324
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170543

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    Viper Prime

    Establishment Types

    Repack or Relabel Medical Device