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    FDA Registration Active 🇲🇾 Malaysia

    EVOLUTION® REVISON FEM DISTAL AUG TRIAL 8MM SIZES 3-5 (E4708345)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    K142550

    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

    Proprietary Names

    EVOLUTION® REVISON FEM DISTAL AUG TRIAL 8MM SIZES 3-5 (E4708345) EVOLUTION® REVISON FEM DISTAL AUG TRIAL 4MM SIZES 6-8 (E4704678) EVOLUTION® REVISON FEM POST AUG TRIAL 12MM SIZES 3-5 (E4612345) EVOLUTION® REVISON FEM DISTAL AUG TRIAL 12MM SIZES 3-5 (E4712345) EVOLUTION® MP™ ADAPTIVE CS INSERT TRIAL SZ 2/1 RIGHT 10MM (EAT2110R) ADVANCE® TRIAL STEM EXTENSION 16 x 100mm (K0050016) ADVANCE® TRIAL STEM EXTENSION 13 x 100mm (K0050013) ADVANCE® TRIAL STEM EXTENSION 17 x 100mm (K0050017) ADVANCE® TRIAL STEM EXTENSION 15 x 100mm (K0050015)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)