BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    EVOLVE™ HEAD 24MM +4 (496H424)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    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
    K991915

    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, Elbow, Hemi-, Radial, Polymer KWI

    Proprietary Names

    EVOLVE™ HEAD 24MM +4 (496H424) EVOLVE™ STEM 5.5MM (496S055) EVOLVE™ STEM 6.5MM +4 (496S465) EVOLVE™ STEM 8.5MM +4 (496S485) EVOLVE™ STEM 8.5MM (496S085) EVOLVE™ HEAD 22MM +2 (496H222) EVOLVE™ STEM 7.5MM +4 (496S475) EVOLVE™ STEM 5.5MM +4 (496S455) EVOLVE™ HEAD 28MM (496H028) EVOLVE™ HEAD 28MM +4 (496H428) EVOLVE™ STEM 6.5MM (496S065) EVOLVE™ HEAD 22MM (496H022) EVOLVE™ HEAD 20MM +2 (496H220) EVOLVE™ HEAD 26MM +2 (496H226) EVOLVE™ HEAD 24MM +2 (496H224) EVOLVE™ HEAD 20MM +4 (496H420) EVOLVE™ HEAD 28MM +2 (496H228) EVOLVE™ HEAD 26MM +4 (496H426) EVOLVE™ STEM 7.5MM (496S075) EVOLVE™ HEAD 22MM +4 (496H422) EVOLVE™ STEM 9.5MM +4 (496S495) EVOLVE™ HEAD 26MM (496H026) EVOLVE™ HEAD 20MM (496H020) EVOLVE™ HEAD 24MM (496H024) EVOLVE™ STEM 9.5MM (496S095)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)