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    FDA Registration Active 🇲🇾 Malaysia

    2 FO Micro Screw 11mm (Cannulated) (MSCP-1120)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    43
    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
    K180348

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    2 FO Micro Screw 11mm (Cannulated) (MSCP-1120) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0016) 2 FO Micro Screw 12mm (Cannulated) (MSCP-1220) 2 FO Micro Screw 14mm (Cannulated) (MSCP-1420) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0001) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0004) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw ((FOSCR0002) 1.5 FO Micro Screw 16mm (Cannulated) (MSCP-1615) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0006) 1.5 FO Micro Screw 7mm (Cannulated) (MSCP-0715) 2 FO Micro Screw 6mm (Cannulated) (MSCP-0620) 1.5 FO Micro Screw 11mm (Cannulated) (MSCP-1115) 2 FO Micro Screw 10mm (Cannulated) (MSCP-1020) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0009) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0003) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0020) 2 FO Micro Screw 9mm (Cannulated) (MSCP-0920) 1.5 FO Micro Screw 10mm (Cannulated) (MSCP-1015) 2 FO Micro Screw 15mm (Cannulated) (MSCP-1520) 1.5 FO Micro Screw 8mm (Cannulated) (MSCP-0815) 1.5 FO Micro Screw 15mm (Cannulated) (MSCP-1515) 2 FO Micro Screw 8mm (Cannulated) (MSCP-0820) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0013) 1.5 FO Micro Screw 6mm (Cannulated) (MSCP-0615) 1.5 FO Micro Screw 22mm (Cannulated) (MSCP-2215) 2 FO Micro Screw 7mm (Cannulated) (MSCP-0720) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0010) 1.5 FO Micro Screw 12mm (Cannulated) (MSCP-1215) 1.5 FO Micro Screw 14mm (Cannulated) (MSCP-1415) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0008) 2 FO Micro Screw 13mm (Cannulated) (MSCP-1320) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0017) 2 FO Micro Screw 16mm (Cannulated) (MSCP-1620) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0007) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0019) Field Orthopaedics Micro Screw Project Component Drawing HA1.5 Hex Screw (FOSCR0005) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0018) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0021) 1.5 FO Micro Screw 13mm (Cannulated) (MSCP-1315) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0015) 1.5 FO Micro Screw 9mm (Cannulated) (MSCP-0915) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0014) Field Orthopaedics Micro Screw Project Component Drawing HA2 Hex Screw (FOSCR0022)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)