BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    2mm Shift Block (2201-311-818)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    2

    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
    K120038

    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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    2mm Shift Block (2201-311-818) A200 Modular Femoral Sizer Posterior Referencing (2201-311-010) Tibial Alignment Tower (2203-321-043) A200 4-In-1 Block Size 4/4N (2201-311-814) Tibial I/M Guide (2203-321-006) A200 4-In-1 Block Size 2 (2201-311-812) Modular Spike Long (2201-311-820) Modular Spike Standard (2201-311-819) Tibial Drill Guide Size 0-2 (2201-322-051) Intramedullary Rod (2203-301-033) Drill Guide Handle II (2201-322-007) Modular Patella Template/Drill Guide, Intech Modular Size 4 (2201-332-056) Modular Patella Template/Drill Guide, Intech Modular Size 2 (2201-332-054) Modular Patella Template/Drill Guide, Intech Modular Size 1 (2201-332-053) Slap Hammer End (2201-311-007) A200 4-In-1 Block Size 1 (2201-311-811) A200 4-In-1 Block Size 5 (2201-311-815) Knee System Stop Drill, Femoral - Tibial - Patella (2201-301-044) Angel Wing (2201-301-024) Tibial Drill Guide Size 3-8 (2201-322-052) A200 4-In-1 Block Size 7 (2201-311-817) A200 4-In-1 Block Size 6 (2201-311-816) Modular Patella Template/Drill Guide, Intech Modular Size 3 (2201-332-055) Intramedullary Drill Bit (2201-301-043) A200 4-In-1 Block Size 3/3N (2201-311-813) Modular Patella Template/Drill Guide, Intech Modular Size 5 (2201-332-057)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)