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    FDA Registration Active 🇲🇾 Malaysia

    Cr Cemented Femoral Size 2 (101-11302-002)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    92
    Establishment Types
    1
    Classifications
    3

    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
    K191084

    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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Cr Cemented Femoral Size 2 (101-11302-002) 101-51056 (Angel Wing) TIBIAL TRAY NONPOROUS SIZE-2 (101-12002-I) TIBIAL TRAY NONPOROUS SIZE-1 (101-12001-I) PATELLA STYLUS 9MM (101-54007) TIBIAL TRAY TEMPLATE SIZE 6 (101-52600) TIBIAL KEEL PUNCH GUIDE SIZE 1,2,3 (101-52013) AUXILLARY PEG DRILL SHORT (101-52010) FEMORAL DRILL (101-51048) DISTAL FEMORAL ALIGNMENT GUIDE (101-51004) 3.2MM HEADED NAILS (101-52006) TIBIAL TRAY TEMPLATE SIZE 3 (101-52300) TIBIAL RESECTION GUIDE ASSEMBLY (101-52002) TIBIAL TRAY TEMPLATE SIZE 7 (101-52700) TIBIAL KEEL PUNCH SIZE 1.2.3 (101-52113) TIBIAL KEEL PUNCH GUIDE SIZE 4,5,6 (101-52046) TIBIAL TRAY CENTRAL DRILL 16MM (101-52007) FEMORAL ANGULAR ALIGNMENT (101-51003) TIBIAL TRAY TEMPLATE SIZE 4 (101-52400) PATELLA DRILL (101-54012) TIBIAL TRAY TEMPLATE SIZE 5 (101-52500) TIBIAL KEEL PUNCH GUIDE SIZE 7,8 (101-52078) TIBIAL TRAY TEMPLATE SIZE 8 (101-52800) TIBIAL TRAY TEMPLATE SIZE 2 (101-52200) TIBIAL TRAY CENTRAL DRILL 17MM (101-52009) TIBIAL KEEL PUNCH SIZE 7,8 (101-52178) PATELLA STYLUS 10MM (101-54008) TIBIAL KEEL PUNCH SIZE 4,5,6 (101-52146) TIBIAL TRAY TEMPLATE SIZE 1 (101-52100) 101-15140 Stem Diameter 14 X 25mm, Titanium 101-15124 Stem Diameter 12 X 50mm, Titanium Femoral Sizer (101-51057) 101-15120 Stem Diameter 12 X 25mm, Titanium 101-15121 Stem Diameter 12 X 75mm, Titanium Femoral Chamfer Cut Block Size 7 (101-51013) Femoral Trial Universal Sz 2 (101-51016) Femoral Drill (101-51048) Femoral Chamfer Cut Block Size 5 (101-51011) Patella Sizer 39mm (101-54018) Cr Cemented Femoral Size 2 (101-11302-001) Stationary Tibial Resection Guide (101-52036) Femoral Trial Universal Sz 5 (101-51019) Femoral Trial Universal Sz 6 (101-51020) FEMORAL IM ROD (101-51001) Cr Cemented Femoral Size 1 (101-11301-002) Patella Sizer 33mm (101-54016) 101-15144 Stem Diameter 14 X 50mm, Titanium Tibial Stylus 2-11 mm (101-52008) PATELLA CEMENT CLAMP ANTERIOR SIDE (101-54014) Angel Wing (101-51056) Cr Cemented Femoral Size 4 (101-11304-002) Cr Cemented Femoral Size 3 (101-11303-002) Cr Cemented Femoral Size 3 (101-11303-001) Femoral Chamfer Cut Block Size 3 (101-51009) Femoral Chamfer Cut Block Size 1 (101-51007) Femoral Trial Universal Sz 1 (101-51015) Femoral Chamfer Cut Block Size 4 (101-51010) Tibial Stylus 4-9 mm (101-52004) Femoral Chamfer Cut Block Size 8 (101-51014) Distal Femoral Alignment Guide (101-51004) Patella Sizer 36mm (101-54017) Tibial Base Plate Impactor Assembly (101-52016) TIBIAL TRAY NONPOROUS SIZE-7 (101-12007-I) Femoral Trial Universal Sz 3 (101-51017) Tibial Tray Cemented Size-3 (101-12003) Cr Cemented Femoral Size 4 (101-11304-001) 101-15101 Stem Diameter 10 X 75mm, Titanium Femoral Trial Universal Sz 8 (101-51022) Curved Osteotome (101-51061) Patella Cement Clamp Anterior Side (101-54014) Tibial Stem Drill 12mm Bushing (101-52043) Femoral Driver (101-51052) Tibial Tray Impactor (101-52031) Gap Gage 13mm And 15mm (101-52027) 12mm Tibial Stem Drill (101-52050) Femoral Chamfer Cut Block Size 6 (101-51012) 101-54014 (Patella Cement Clamp Anterior Side) Tibial Tray Cemented Size-4 (101-12004) Femoral Trial Universal Sz 7 (101-51021) Femoral Trial Universal Sz 4 (101-51018) Gap Gage 9mm And 11mm (101-52026) Aux Peg Punch Long (101-52014) Connector Em Guide-Resection Guide-3deg (101-52011) Tibial Tray Cemented Size-5 (101-12005) ANGEL WING (101-51056 ) Femoral Sizer 1 (101-51070) Femoral Chamfer Cut Block Size 2 (101-51008) Gap Gage 17mm And 19mm (101-52028) Tibial Insert Impactor (101-52017) TIBIAL TRAY NONPOROUS SIZE-5 (101-12005-I) Patella Drill Guide (101-54013) Connector Em Guide-Resection Guide 0 Deg (101-52012)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)