BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 22mm LENGTH (49000722)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    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
    K994061

    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

    Proprietary Names

    LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 22mm LENGTH (49000722) LOCON-T™ ALUMINUM BENDINGTEMPLATE DORSAL MEDIUM (24900017) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 6mm LENGTH (49000706) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 40mm LENGTH (49000740) LOCON-T™ VOLAR PLATE (4900000V) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 8mm LENGTH (49000708) LOCON-T™ DISTAL RADIAL PLATERIGHT DORSAL SMALL (49000SMR) CORTICAL BONE SCREW 3.5 X 18MMDISTAL RADIUS (49000718) LOCON-T™ ALUMINUM BENDINGTEMPLATE DORSAL LARGE (24900016) LOCON-T™ DISTAL RADIAL PLATELEFT DORSAL MEDIUM (49000MDL) CORTICAL BONE SCREW 3.5 X 12MMDISTAL RADIUS (49000712) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 30mm LENGTH (49000730) CORTICAL BONE SCREW 3.5 X 14MMDISTAL RADIUS (49000714) LOCON-T™ DISTAL RADIAL PLATERIGHT DORSAL LARGE (49000LGR) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 24mm LENGTH (49000724) CORTICAL BONE SCREW 3.5 X 20MMDISTAL RADIUS (49000720) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 38mm LENGTH (49000738) CORTICAL BONE SCREW 3.5 X 16MMDISTAL RADIUS (49000716) LOCON-T™ DISTAL RADIAL PLATELEFT DORSAL SMALL (49000SML) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 36mm LENGTH (49000736) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 34mm LENGTH (49000734) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 32mm LENGTH (49000732) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 10mm LENGTH (49000710) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 26mm LENGTH (49000726) LOCON-T™ DISTAL RADIAL PLATELEFT DORSAL LARGE (49000LGL) LOCON-T™ CORTICAL BONE SCREW3.5mm DIAMETER 28mm LENGTH (49000728) LOCON-T™ ALUMINUM BENDINGTEMPLATE DORSAL SMALL (24900018) LOCON-T™ DISTAL RADIAL PLATERIGHT DORSAL MEDIUM (49000MDR) LOCON-T™ DORSAL PLATELATERAL EXTENDER (4900000E)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)