BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    CURVED 3.5MM PLATE 18 HOLE, NON-STERILE

    Reg #: 9616944 · FEI: 3003414678 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SYNTEC SCIENTIFIC CORP.
    Registration Number
    9616944
    FEI Number
    3003414678
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, KUNG SAN ROAD, CHUAN SHING, INDUSTRIAL ZONE, SHEN KANG
    City
    CHANG HUA Changhua
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K142836

    Owner / Operator

    Firm Name
    Syntec Scientific Corporation
    Operator Number
    9034982
    Address
    No.2, Kung San Rd., Chuan Shing Industrial Zone, Shen Kang
    City
    Chang Hua Hsien
    State
    Changhua
    Postal Code
    509
    Country
    TW
    Correspondent
    PETER CHANG

    Products

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

    Proprietary Names

    CURVED 3.5MM PLATE 18 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 12 HOLE NON-STERILE CURVED 3.5MM PLATE 12 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 14 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 22 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 16 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 7 HOLE, NON-STERILE CURVED 3.5MM PLATE 6 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 10 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 4 HOLE, NON-STERILE CURVED 3.5MM PLATE 14 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 15 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 6 HOLE, NON-STERILE CURVED 3.5MM PLATE 16 HOLE, NON-STERILE CURVED 3.5MM PLATE 20 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 13 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 3 HOLE, NON-STERILE CURVED 3.5MM PLATE 8 HOLE, NON-STERILE CURVED 3.5MM PLATE 10 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 5 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 20 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 9 HOLE, NON-STERILE CURVED 3.5MM PLATE 24 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 18 HOLE NON-STERILE CURVED 3.5MM PLATE 22 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 11 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 8 HOLE, NON-STERILE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)