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    FDA Registration Active 🇲🇾 Malaysia

    4942012L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    21
    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
    K111432

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    4942012L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING 4942035N EVOLVE™TRIAD™ SCREW 2X35MM 145161 ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING 4942018L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING 4942022L, 26L, 28L, 30L LISFRANC SCREW 4.5 X [TAB] CHARLOTTE® F&A SCREW 4942014N EVOLVE™TRIAD™ SCREW 2X14MM 4941520N EVOLVE™TRIAD™ SCREW 1.5X20MM 4942016L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING 4941522N EVOLVE™TRIAD™ SCREW 1.5X22MM 4942024N EVOLVE™TRIAD™ SCREW 2X24MM 4942018N EVOLVE™TRIAD™ SCREW 2X18MM 145162, 67, 68, 69 LISFRANC SCREW 4.5 X [TAB] CHARLOTTE® F&A SCREW 4942010L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING 4942022N EVOLVE™TRIAD™ SCREW 2X22MM 4942020N EVOLVE™TRIAD™ SCREW 2X20MM 4942020L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING 4942016N EVOLVE™TRIAD™ SCREW 2X16MM 4941524N EVOLVE™TRIAD™ SCREW 1.5X24MM 4941518N EVOLVE™TRIAD™ SCREW 1.5X18MM 4942014L ORTHOLOC MINI SCREW 2 X [TAB] POLYAXIAL LOCKING Ortholoc™ Mini Screw 2 X 30mm Polyaxial Locking (4942030L)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)