BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    OLYMPIA™ KEELED GLENOIDTRIAL 52MM (2870GK52)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Straits Orthopaedics (MFG) Sdn Bhd
    Registration Number
    3004889950
    FEI Number
    3004889950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K002683

    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, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    OLYMPIA™ KEELED GLENOIDTRIAL 52MM (2870GK52) OLYMPIA™ KEELED GLENOIDTRIAL 60MM (2870GK60) OLYMPIA™ CLEAR GLENOIDTRIAL 60MM (2870GC60) OLYMPIA™ CLEAR GLENOIDTRIAL 48MM (2870GC48) OLYMPIA™ CLEAR GLENOIDTRIAL 56MM (2870GC56) OLYMPIA™ KEELED GLENOIDTRIAL 44MM (2870GK44) OLYMPIA™ KEELED GLENOIDTRIAL 56MM (2870GK56) OLYMPIA™ CLEAR GLENOIDTRIAL 52MM (2870GC52) OLYMPIA™ CLEAR GLENOIDTRIAL 44MM (2870GC44) OLYMPIA™ CLEAR GLENOIDTRIAL 40MM (2870GC40) OLYMPIA™ KEELED GLENOIDTRIAL 40MM (2870GK40) OLYMPIA™ KEELED GLENOIDTRIAL 48MM (2870GK48)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)