BEUDAMED
    FDA Registration Active 🇨🇴 Colombia

    2.5mm FT cannulated cortex screw, pentalock, 28mm-

    Reg #: 3004187715 · FEI: 3004187715 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    66
    Establishment Types
    1
    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
    K191641

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    2.5mm FT cannulated cortex screw, pentalock, 28mm- 2.5mm FT cortex screw, 24mm 2.5mm FT cortex screw, 10mm Extra-articular distal radius plate, narrow, right, 2H Distal ulnar T-plates, 4H 2.5mm FT pentalock cortex screw, 20mm- 2.5mm PT cannulated cortex screw, 30mm Distal dorso-ulnar and dorso-radial L-plates, left, 4H 2.5mm PT cannulated cortex screw, 22mm 2.5mm FT cortex screw, 28mm 2.5mm FT pentalock cortex screw, 16mm- Distal dorso-ulnar and dorso-radial L-plates, left, 6H 2.5mm FT cortex screw, 20mm 2.5mm FT pentalock cortex screw, 18mm- Extra-articular distal radius plate, wide, left, 3H 2mm pentalock peg, 30mm- Distal ulnar T-plates, 6H 2.5mm FT pentalock cortex screw, 14mm- Extra-articular distal radius plate, intermediate, left, 7H 2.5mm FT cortex screw, 16mm 2mm pentalock peg, 12mm- Extra-articular distal radius plate, wide, right, 3H Distal dorso-ulnar and dorso-radial L-plates, right, 4H 2mm pentalock peg, 18mm- 2.5mm FT pentalock cortex screw, 22mm- 2mm pentalock peg, 22mm- 2.5mm FT pentalock cortex screw, 28mm- AFFINITY - Variable Angle Distal Radius System 2.5mm FT cortex screw, 18mm Extra-articular distal radius plate, intermediate, left, 2H 2mm pentalock peg,10mm- Extra-articular distal radius plate, intermediate, left, 3H 2.5mm PT cannulated cortex screw, 26mm 2.5mm FT cortex screw, 12mm Radius styloid plates, straight, 6H 2mm pentalock peg, 26mm- 2mm pentalock peg, 28mm- Radius styloid plates, straight, 4H 2.5mm PT cannulated cortex screw, 20mm Extra-articular distal radius plate, intermediate, right, 2H Extra-articular distal radius plate, narrow, left, 3H 2.5mm FT pentalock cortex screw, 26mm- 2.5mm FT cannulated cortex screw, pentalock, 26mm- 2.5mm FT cortex screw, 22mm 2.5mm FT cannulated cortex screw, pentalock, 22mm- Extra-articular distal radius plate, narrow, right, 3H 2mm pentalock peg, 14mm- 2mm pentalock peg, 20mm- 2.5mm FT cortex screw, 14mm 2.5mm PT cannulated cortex screw, 24mm Distal dorso-ulnar and dorso-radial L-plates, right, 6H 2.5mm FT pentalock cortex screw, 24mm- 2mm pentalock peg, 16mm- 2.5mm PT cannulated cortex screw, 28mm Extra-articular distal radius plate, intermediate, right, 3H 2.5mm FT cannulated cortex screw, pentalock, 24mm- 2.5mm FT cortex screw, 26mm 2mm pentalock peg, 24mm- 2.5mm FT pentalock cortex screw, 12mm- Extra-articular distal radius plate, intermediate, right, 7H 2.5mm FT cannulated cortex screw, pentalock, 30mm- 2.5mm FT cortex screw, 30mm Extra-articular distal radius plate, narrow, left, 2H 2.5mm FT cannulated cortex screw, pentalock, 20mm- 2.5mm FT pentalock cortex screw, 10mm- 2.5mm FT pentalock cortex screw, 30mm-

    Establishment Types

    Manufacture Medical Device