BEUDAMED
    FDA Registration Active 🇨🇴 Colombia

    3.5mm Self-Tapping Cortex Screws, TI, 42mm

    Reg #: 3004187715 · FEI: 3004187715 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    87
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    INDUSTRIAS MEDICAS SAMPEDRO S.A.S
    Registration Number
    3004187715
    FEI Number
    3004187715
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Carrera 47 100 Sur 40 Bodega 14
    City
    La Estrella Antioquia
    Country
    CO

    Regulatory Submissions

    510(k) Number
    K220199

    Owner / Operator

    Firm Name
    INDUSTRIAS MEDICAS SAMPEDRO S.A.S
    Operator Number
    10062588
    Address
    Carrera 47 100 Sur 40 Bodega 14
    City
    La Estrella
    State
    Antioquia
    Postal Code
    055468
    Country
    CO
    Correspondent
    Maritza Buitrago-Vasquez

    US Agent

    Business Name
    Techfit Digital Surgery Inc
    Contact Name
    Laura Buitrago
    Address
    1511 Aviation Center Pkwy Ste 220H, Daytona Beach, Florida, 32114, UNITED STATES
    City
    Daytona Beach
    State
    FL
    ZIP
    32114
    Country
    US
    Email
    [email protected]
    Phone
    929 2488135

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    3.5mm Self-Tapping Cortex Screws, TI, 42mm 3.5mm Self Tapping Locking Screw, Pentalock, 90mm 3.5mm Self Tapping Locking Screw, Pentalock, 36mm 3.5mm Self-Tapping Cortex Screws, TI, 30mm 3.5mm Self Tapping Locking Screw, Pentalock, 48mm Lateral Proximal Tibia Plate -10H - Left 3.5mm Self-Tapping Cortex Screws, TI, 65mm 3.5mm Self-Tapping Cortex Screws, TI, 24mm Medial Proximal Tibia Plate -14H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 75mm 3.5mm Self Tapping Locking Screw, Pentalock, 30mm 3.5mm Self-Tapping Cortex Screws, TI, 28mm 3.5mm Self Tapping Locking Screw, Pentalock, 85mm 3.5mm Self Tapping Locking Screw, Pentalock, 80mm 3.5mm Self Tapping Locking Screw, Pentalock, 50mm 3.5mm Self Tapping Locking Screw, Pentalock, 70mm Medial Proximal Tibia Plate -8H - Right AFFINITY Lateral Proximal Tibia Plate -6H - Right Medial Proximal Tibia Plate -6H - Left 3.5mm Self-Tapping Cortex Screws, TI, 85mm 3.5mm Self-Tapping Cortex Screws, TI, 70mm Medial Proximal Tibia Plate -16H - Right Medial Proximal Tibia Plate -18H - Left Medial Proximal Tibia Plate -4H - Left 3.5mm Self-Tapping Cortex Screws, TI, 80mm 3.5mm Self-Tapping Cortex Screws, TI, 40mm Lateral Proximal Tibia Plate -10H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 95mm Lateral Proximal Tibia Plate -18H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 38mm 3.5mm Self-Tapping Cortex Screws, TI, 18mm 3.5mm Self-Tapping Cortex Screws, TI, 22mm Medial Proximal Tibia Plate -8H - Left 3.5mm Self-Tapping Cortex Screws, TI, 60mm Medial Proximal Tibia Plate -12H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 46mm Medial Proximal Tibia Plate -14H - Left Lateral Proximal Tibia Plate -12H - Left Medial Proximal Tibia Plate -10H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 24mm 3.5mm Self Tapping Locking Screw, Pentalock, 26mm Lateral Proximal Tibia Plate -14H - Left 3.5mm Self-Tapping Cortex Screws, TI, 48mm Lateral Proximal Tibia Plate -2H - Left 3.5mm Self Tapping Locking Screw, Pentalock, 18mm Lateral Proximal Tibia Plate -8H - Left Medial Proximal Tibia Plate -2H - Right 3.5mm Self-Tapping Cortex Screws, TI, 34mm 3.5mm Self Tapping Locking Screw, Pentalock, 55mm Lateral Proximal Tibia Plate -16H - Right 3.5mm Self-Tapping Cortex Screws, TI, 95mm 3.5mm Self Tapping Locking Screw, Pentalock, 42mm Medial Proximal Tibia Plate -4H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 65mm 3.5mm Self-Tapping Cortex Screws, TI, 75mm Medial Proximal Tibia Plate -2H - Left Lateral Proximal Tibia Plate -16H - Left Medial Proximal Tibia Plate -6H - Right Lateral Proximal Tibia Plate -8H - Right 3.5mm Self-Tapping Cortex Screws, TI, 90mm 3.5mm Self-Tapping Cortex Screws, TI, 50mm 3.5mm Self-Tapping Cortex Screws, TI, 20mm Lateral Proximal Tibia Plate -18H - Right Medial Proximal Tibia Plate -12H - Right Lateral Proximal Tibia Plate -12H - Right Medial Proximal Tibia Plate -18H - Right Medial Proximal Tibia Plate -10H - Right 3.5mm Self Tapping Locking Screw, Pentalock, 28mm Lateral Proximal Tibia Plate -2H - Right Medial Proximal Tibia Plate -16H - Left 3.5mm Self-Tapping Cortex Screws, TI, 38mm 3.5mm Self Tapping Locking Screw, Pentalock, 22mm Lateral Proximal Tibia Plate -6H - Left Lateral Proximal Tibia Plate -4H - Left 3.5mm Self-Tapping Cortex Screws, TI, 44mm 3.5mm Self Tapping Locking Screw, Pentalock, 32mm 3.5mm Self Tapping Locking Screw, Pentalock, 44mm 3.5mm Self Tapping Locking Screw, Pentalock, 40mm 3.5mm Self Tapping Locking Screw, Pentalock, 60mm 3.5mm Self-Tapping Cortex Screws, TI, 36mm 3.5mm Self-Tapping Cortex Screws, TI, 32mm Lateral Proximal Tibia Plate -4H - Right 3.5mm Self-Tapping Cortex Screws, TI, 26mm 3.5mm Self-Tapping Cortex Screws, TI, 55mm 3.5mm Self-Tapping Cortex Screws, TI, 46mm 3.5mm Self Tapping Locking Screw, Pentalock, 34mm

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198