BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ETRAMEDULLARY ALIGNMENT ROD (114861)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    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
    K113038

    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
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    ETRAMEDULLARY ALIGNMENT ROD (114861) RIMMED SPEED PIN 65MM STERILE (81116663, 74013472) NON RIMMED SPEED PIN 65MM STERILE (81116664, 74013480) NON RIMMED SPEED PIN 80MM STERILE (81116665, 74013490) NON RIMMED SPEED PIN 110MM STERILE (81116660, 74013401) RIMMED SPEED PIN 30MM STERILE (81116661, 74013470) RIMMED SPEED PIN 45MM STERILE (81116662, 74013471)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)