BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Legion Hinge Tibia Trial Post Bolt - 11mm x 1.153 (71434395)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3025603301
    FEI Number
    3025603301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1264, Lorong PSPN 1, Penang Science Park North
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K121393

    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/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    Legion Hinge Tibia Trial Post Bolt - 11mm x 1.153 (71434395) Legion Hinge Tibia Trial Post Bolt - 15mm x 1.310 (71434397) Legion Hinge Tibia Trial Post Bolt - 21mm x 1.547 (71434399) Legion Hinge Tibia Trial Post Bolt - 18mm x 1.428 (71434398) Legion Hinge Tibia Trial Post Bolt - 13mm x 1.232 (71434396) Parallel Bars (114886) Quick Connect Trocar Pin 1/8" x 3"(74012904) Quick Connect Trocar Pin 1/8" x 3"(81021261) GNS II STEMLESS TIB TR SZ 5 LT (71430169)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)