BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Salvation™ Quick Strut Medium (SEF11002)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K162033

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Salvation™ Quick Strut Medium (SEF11002) SALVATION™ QUICK STRUT LONG (SEF11003) SALVATION™ QUICK STRUT MEDIUM (SEF11002) SALVATION™ 220MM TAB HALF RING (SEF07225) Salvation™ Quick Strut Long (SEF11003) SALVATION™ QUICK STRUT SHORT (SEF11001) Salvation™ Quick Strut Short (SEF11001) SALVATION™ 220MM TAB 5/8 RING (SEF07228) Salvation™ 140MM Tab Haft Ring (SEF07145) SALVATION™ 140MM TAB 5/8 RING FULL (SEF07148) SALVATION™ 200MM TAB HALF RING (SEF07205) SALVATION™ 180MM TAB HALF RING (SEF07185) SALVATION™ 220MM 5/8 RING SLOTTED (SEF58022) Salvation™ 180mm Tab 5/8 Ring Full (SEF07188) SALVATION™ 200MM TAB 5/8 RING FULL (SEF07208) SALVATION™ 160MM TAB HALF RING (SEF07165) SALVATION™ 160MM TAB 5/8 RING (SEF07168)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)