BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    2 L-PLT, OBLIQUE RIGHT

    Reg #: 9616944 · FEI: 3003414678 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    1

    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
    K141517

    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

    Proprietary Names

    2 L-PLT, OBLIQUE RIGHT 2 L-PLT, LEFT 1.5 T-PLT, 3HL-HEAD, 9HL-SHAFT 2 STRAIGHT PLT, 4 HOLE 2 STRAIGHT PLT, 3 HOLE 2 STRAIGHT PLT, 20 HOLE 2 L-PLT, OBLIQUE LEFT 2 H-PLT, 4 HOLE 2 T-PLT, 3HL-HEAD, 9HL-SHAFT 2 L-PLT, RIGHT 2 STRAIGHT PLT, 5 HOLE 1.5 CONDYLAR PLT, RIGHT 2 CONDYLAR PLT, RIGHT 1.5 H-PLT, 4 HOLE 2 CONDYLAR PLT, LEFT 3.5 CALCANEAL Y-PLT, 87MM 1.5 T-PLT, 4HL-HEAD, 9HL-SHAFT 3.5 CALCANEAL PLT, 60MM 2.7 CONDYLAR PLT, LEFT 2 T-PLT, 4HL-HEAD, 9HL-SHAFT 3.5 CALCANEAL PLT, 70MM 2.7 CONDYLAR PLT, RIGHT 2 T-PLT 2 STRAIGHT PLT,6 HOLE 1.5 STRAIGHT PLT, 20 HOLE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)