BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Trial Shell Size 60 (MO10281M/0)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    57
    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
    K143314

    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    Trial Shell Size 60 (MO10281M/0) Femoral Head Trial Size 32 (MO10303M) M-1410-3200 Calcar Planner (MO10324M) M-1500-1017 Trial Elevated Liner Size 54-56x32 (MO10669M) Elevated Trial Liner Size 52x32 (MO10647M) STD Trial Liner Size 54-56x36 (MO10650M) STD Trial Liner Size 50x32 (MO10299M) Drill Guide (MO10318M) Trial Shell Size 50 (MO10276M/0) Adaptor Trial ASM XL (MO10371M) M-1435-2804 Trial Shell Size 48 (MO10275M/0) Trial Adaptor Small (MO10368M) M-1435-2801 Trial Shell Size 52 (MO10277M/0) Cup Alignment Guide (MO10323M) Trial Elevated Liner Size 50x32 (MO10306M) STD Trial Liner Size 54-56x32 (MO10649M) STD Trial Liner Size 46-48-28 (MO10648M) T-Handle Starter Awl (MO10320M) M-1500-1012 Trial Shell Size 58 (MO10280M/0) Dome Impactor Size 2 (MO10326M) M-1500-2802 Femoral Head Trial Size 36 (MO10304M) M-1400-3600 Stem Impactor (MO10314M) M-1500-1001 Femoral Head Trial Size 28 (MO10302M) M-1410-2800 Shell Impactor (MO10316M) Trial Shell Size 46 (MO10274M/0) Trial Elevated Liner Size 58-60x32 (MO10671M) Stem Extractor (MO10315M) M-1500-1002 Trial Shell Size 62 (MO10282M/0) 3.5mm Pivot Driver (MO10321M) STD Trial Liner Size 62-64x36 (MO10653M) Trial Elevated Liner Size 54-56x36 (MO10670M) Dome Impactor Size 3 (MO10327M) M-1500-3601 Trial Adaptor Medium (MO10369M) M-1435-2802 Trial Shell Size 68 (MO10285M/0) STD Trial Liner Size 52x28 (MO10643M) Trial Shell Size 64 (MO10283M/0) STD Trial Liner Size 50x28 (MO10641M) Trial Shell Size 54 (MO10278M/0) STD Trial Liner Size 52x36 (MO10300M) Elevated Trial Liner Size 50x28 (MO10645M) Elevated Trial Liner Size 52x28 (MO10646M) Dome Impactor Size 1 (MO10325M) M-1500-2801 Head Impactor (MO10317M) M-1500-1004 Trial Shell Size 56 (MO10279M/0) Ext. Offset Neck Trial (MO10309M) M-1425-0722 Trial Elevated Liner Size 58-60x36 (MO10672M) STD Offset Neck Trial W/Magnet (MO10287M) M-1400-0622 STD Trial Liner Size 58-60x32 (MO10651M) Spacer Shell Impactor (MO10322M) Trial Shell Size 66 (MO10284M/0) Osteo Cutter, Angled Box (MO10319M) M-1500-1011 STD Trial Liner Size 58-60x36 (MO10652M) Trial Elevated Liner Size 52x36 (MO10307M) STD Trial Liner Size 66-68x36 (MO10654M) Trial Adaptor Large (MO10370M) M-1435-2803 STD Trial Liner Size 52x32 (MO10644M) Trial Elevated Liner Size 66-68x36 (MO10674M)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)