BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRIANGULAR MICRO PLATE N 5pc

    Reg #: 1000606483 · FEI: 1000606483 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    82
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MCI MEDICAL CONCEPT INNOVATION INC.
    Registration Number
    1000606483
    FEI Number
    1000606483
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4592 North Hiatus Road
    City
    Sunrise
    State
    FL
    ZIP
    33351
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212391

    Owner / Operator

    Firm Name
    MCI MEDICAL CONCEPT INNOVATION INC.
    Operator Number
    10057752
    Address
    4592 North Hiatus Road
    City
    Sunrise
    State
    FL
    Postal Code
    33351
    Country
    US
    Correspondent
    Osmar Teixeira

    Products

    Device Name Product Code
    Plate, Cranioplasty, Preformed, Alterable GWO
    Fastener, Plate, Cranioplasty HBW
    Cover, Burr Hole GXR

    Proprietary Names

    TRIANGULAR MICRO PLATE N 5pc MICRO PLATE N FOR CRANIOTOMY D18mm DRAIN 6mm AUTO DRIVE SCREW N 1.7 X 4mm 20pc AUTO DRIVE SCREW N 1.7 X 5mm 5pc RECTANGULAR MICRO PLATE N 4X2H TR STRAIGHT MICRO PLATE N BRIDGE 8mm 2H MICRO PLATE N FOR CRANIOTOMY D22mm #0.3mm CLOVER MICRO PLATE N AUTO DRIVE SCREW N 1.7 X 4mm STRAIGHT MICRO PLATE N BRIDGE 8mm 2H 5pc MICRO PLATE N FOR CRANIOTOMY D18mm DRENO 3.2mm RECTANGULAR MICRO PLATE N 3X2H MICRO PLATE N FOR CRANIOTOMY D20mm TR STRAIGHT MICRO PLATE N BRIDGE 12mm 2H 5pc STRAIGHT MICRO PLATE N BRIDGE 12mm 2H 5pc TR STRAIGHT MICRO PLATE N BRIDGE 10mm 2H 5pc AUTO DRIVE SCREW N 1.7 X 5mm 20pc SQUARE MICRO PLATE N 2X2H 5pc TRIANGULAR MICRO PLATE N AUTO DRIVE SCREW N 1.5 X 6mm 20pc STRAIGHT MICRO PLATE N 16H 5pc MICRO PLATE N FOR CRANIOTOMY D22mm #0.3mm 5pc MICRO PLATE N FOR CRANIOTOMY D15mm 5pc CLOVER MICRO PLATE N 5pc STRAIGHT MICRO PLATE N BRIDGE 12mm 2H MICRO PLATE N FOR CRANIOTOMY D12mm #0.3mm 5pc SQUARE MICRO PLATE N 2X2H MICRO PLATE N FOR CRANIOTOMY D18mm DRENO 3.2mm 5pc AUTO DRIVE SCREW N 1.5 X 4mm 20pc X MICRO PLATE N BRIDGE 9mm X MICRO PLATE N BRIDGE 7mm 5pc STRAIGHT MICRO PLATE N BRIDGE 10mm 2H AUTO DRIVE SCREW N 1.5 X 3mm MICRO PLATE N FOR CRANIOTOMY D20mm 5pc CRANIAL MICRO PLATE N 5H D18.5mm Y MICRO PLATE N BRIDGE 6mm 5H 5pc STRAIGHT MICRO PLATE N BRIDGE 6mm 2H 5pc AUTO DRIVE SCREW N 1.5 X 4mm Y MICRO PLATE N BRIDGE 6mm 5H RECTANGULAR MICRO PLATE N 2X2H I MICRO MESH N 90 X 90mm #0.3mm RECTANGULAR MICRO PLATE N 4X2H 5pc TR STRAIGHT MICRO PLATE N BRIDGE 14mm 2H STRAIGHT MICRO PLATE N 4H 5pc CRANIAL MICRO PLATE N 5H D18.5mm 5pc MICRO PLATE N FOR CRANIOTOMY D12mm #0.3mm STRAIGHT MICRO PLATE N BRIDGE 8mm 2H STRAIGHT MICRO PLATE N 4H AUTO DRIVE SCREW N 1.5 X 6mm 5pc STRAIGHT MICRO PLATE N 16H AUTO DRIVE SCREW N 1.5 X 4mm 5pc STRAIGHT MICRO PLATE N BRIDGE 10mm 2H 5pc X MICRO PLATE N BRIDGE 5mm 5pc STRAIGHT MICRO PLATE N BRIDGE 7mm 2H MICRO PLATE N FOR CRANIOTOMY D17mm #0.3mm 5pc X MICRO PLATE N BRIDGE 7mm STRAIGHT MICRO PLATE N BRIDGE 6mm 2H MICRO PLATE N FOR CRANIOTOMY D15mm STRAIGHT MICRO PLATE N BRIDGE 7mm 2H 5pc RECTANGULAR MICRO PLATE N 3X2H 5pc AUTO DRIVE SCREW N 1.7 X 5mm RECTANGULAR MICRO PLATE N 2X2H 5pc MICRO PLATE N FOR CRANIOTOMY D18mm DRAIN 6mm 5pc X MICRO PLATE N BRIDGE 9mm 5pc TR STRAIGHT MICRO PLATE N BRIDGE 12mm 2H AUTO DRIVE SCREW N 1.7 X 4mm 5pc X MICRO PLATE N BRIDGE 5mm Z MICRO PLATE N 10mm AUTO DRIVE SCREW N 1.5 X 3mm 5pc TR STRAIGHT MICRO PLATE N BRIDGE 10mm 2H TR STRAIGHT MICRO PLATE N BRIDGE 14mm 2H 5pc AUTO DRIVE SCREW N 1.5 X 5mm 20pc AUTO DRIVE SCREW N 1.5 X 6mm Z MICRO PLATE N 10mm 5pc I MICRO MESH N 40 X 40mm #0.3mm I MICRO MESH N 120 X 120mm #0.3mm AUTO DRIVE SCREW N 1.5 X 5mm 5pc AUTO DRIVE SCREW N 1.5 X 5mm MICRO PLATE N FOR CRANIOTOMY D17mm #0.3mm TR MICRO MESH N 50.6 X 74.6mm #0.3mm TR STRAIGHT MICRO PLATE N BRIDGE 8mm 2H 5pc AUTO DRIVE SCREW N 1.5 X 3mm 20pc

    Establishment Types

    Manufacture Medical Device