BEUDAMED
    FDA Registration Active 🇺🇸 United States

    04-SB-3528 3.5x28mm, Bias Angle Smooth Shank Polyaxial Screw

    Reg #: 3012131184 · FEI: 3012131184 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CURITEVA, INC.
    Registration Number
    3012131184
    FEI Number
    3012131184
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25127 WILL MCCOMB DR
    City
    Tanner
    State
    AL
    ZIP
    35671
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150851

    Owner / Operator

    Firm Name
    Curiteva, Inc.
    Operator Number
    10050404
    Address
    25127 Will McComb Drive
    City
    Tanner
    State
    AL
    Postal Code
    35671
    Country
    US
    Correspondent
    Scott L Steelman

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    04-SB-3528 3.5x28mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4034 4x34mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3538 3.5x38mm, Bias Angle Smooth Shank Polyaxial Screw 04-9011 Tapered Hex Screwdriver 2.5mm (Shaft 04-9013) (Handle 04-9040) 04-SB-4028 4x28mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3536 3.5x36mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4040 4x40mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4032 4x32mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4030 4x30mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4020 4x20mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3522 3.5x22mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3540 3.5x40mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4026 4x26mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3526 3.5x26mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3532 3.5x32mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4036 4x36mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3524 3.5x24mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4022 4x22mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3534 3.5x34mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3520 3.5x20mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4024 4x24mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4038 4x38mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3530 3.5x30mm, Bias Angle Smooth Shank Polyaxial Screw

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)