BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SALVATION™ BUSHING (SEF33400)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    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
    K150004

    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™ BUSHING (SEF33400) SALVATION™ 80MM SPACER (SEF40080) Salvation™ 5 x 25mm Half Pin HA Sterile (SEF525HA) SALVATION™ 60MM SPACER (SEF40060) SALVATION™ WIRE WASHER (SEF34000) SALVATION™ 1 HOLE CUBE (SEF01001) SALVATION™ WIRE 2MM (SEF20000) Salvation™ Wire 6PK 2mm Multipack ( SEF200PK) SALVATION™ OLIVE WIRE 2MM (SEF25000) SALVATION™ 30MM SPACER (SEF40030) SALVATION™ 3 HOLE CUBE (SEF01003) SALVATION™ OLIVE WIRE 6PK (SEF250PK) SALVATION™ 5MM 4 HOLE CUBE (SEF01004) Salvation™ 5 x 40mm Half Pin HA Sterile (SEF540HA) SALVATION™ C WASHER 2.5MM (SEF32500) Salvation™ 5 x 30mm Half Pin HA Sterile (SEF530HA) Salvation™ 5 x 35mm Half Pin HA Sterile (SEF535HA) SALVATION™ D WASHER (SEF33000) SALVATION™ 5MM 2 HOLE CUBE (SEF01002) Salvation™ Olive Wire 6PK 2mm Multipack (SEF250PK)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)