BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Titanium Screw, Torx,18mm x 2.7mm (NO2825018)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3012217062
    FEI Number
    3012217062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
    City
    Perai Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K022325

    Owner / Operator

    Firm Name
    Straits Orthopaedics (Mfg) Sdn Bhd
    Operator Number
    10048319
    Address
    No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
    City
    Bayan Lepas
    State
    Pulau Pinang
    Postal Code
    11920
    Country
    MY
    Correspondent
    TH SU

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    Titanium Screw, Torx,18mm x 2.7mm (NO2825018) Titanium Screw, Torx,20mm x 2.7mm (NO2825020) Titanium Screw, threaded head,16mm x 3.5mm (NO2820016) Titanium Screw, threaded head,24mm x 3.5mm (NO2820024) Titanium Screw, Torx,30mm x 2.7mm (NO2825030) Titanium Plate, platelocking,3mm (NO2832003) Titanium Screw, nonthreadedhead, 16mm x 3.5mm (NO2820116) Titanium Screw, NonThreadedTorx, 18mm x 2.7mm (NO2825118) UPS 2.7MM PLATE 16MMDARCO® SYSTEM (NO2801116) UPS 3.5MM PLATE 18MMDARCO® SYSTEM (NO2801018) Titanium Screw, Torx,26mm x 2.7mm (NO2825026) Titanium Screw, nonthreadedhead, 28mm x 3.5mm (NO2820128) Titanium Screw, Torx,8mm x 2.7mm (NO2825008) OrthnerLapidus Plate, 6mm step (NO2801006) OrthnerLapidus Plate, 5mm step (NO2801005) Titanium Screw, threaded head,26mm x 3.5mm (NO2820026) UPS 2.7MM PLATE 24MMDARCO® SYSTEM (NO2801124) UPS 3.5MM PLATE 12MMDARCO® SYSTEM (NO2801012) Titanium Screw, Torx,22mm x 2.7mm (NO2825022) Titanium Screw, Torx,24mm x 2.7mm (NO2825024) Titanium Screw, threaded head,30mm x 3.5mm (NO2820030) Titanium Screw, Torx,16mm x 2.7mm (NO2825016)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)