BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Femoral Head Trial Size 28 (MO10302M) M-1410-2800

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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
    K932755

    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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Femoral Head Trial Size 28 (MO10302M) M-1410-2800 Dome Impactor Size 2 (MO10326M) M-1500-3201 Calcar Planner (MO10324M) M-1500-1017 T-Handle Starter Awl (MO10320M) M-1500-1012 Trial Adaptor Large (MO10370M) M-1435-2803 Trial Adaptor Small (MO10368M) M-1435-2801 Stem Impactor (MO10314M) M-1500-1001 Stem Extractor (MO10315M) M-1500-1002 Trial Adaptor Medium (MO10369M) M-1435-2802 Osteo Cutter, Angled Box (MO10319M) M-1500-1011 Femoral Head Trial Size 32 (MO10303M) M-1410-3200 Dome Impactor Size 1 (MO10325M) M-1500-2801 Adaptor Trial ASM XL (MO10371M) M-1435-2804 Femoral Head Trial Size 36 (MO10304M) M-1400-3600 Head Impactor (MO10317M) M-1500-1004 STD Offset Neck Trial W/Magnet (MO10287M) M-1400-0622

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)