BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    6.5mm x 45mm Polyaxial Screw (PA-6545)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3025603301
    FEI Number
    3025603301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1264, Lorong PSPN 1, Penang Science Park North
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K081041

    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
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    6.5mm x 45mm Polyaxial Screw (PA-6545) 7mm x 45mm Polyaxial Screw (PA-7045) Setscrew, Pedicle 4mm – 7mm (PA-4000) 6mm x 110mm Titanium Rod (TR-1611) 6.5mm x 40mm Polyaxial Screw (PA-6540) 6.5mm x 45mm Monoaxial Screw (MA-6545) 6 mm x 300 mm Titanium Rod (TR-1630) 6mm x 300mm Titanium Rod (TR-1630) 6mm x 130mm Titanium Rod (TR-1613)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)