BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    2.7X450MM TRANSSACRAL BEVELED TIP WIRE (2004-0103)

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

    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
    K170021

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    2.7X450MM TRANSSACRAL BEVELED TIP WIRE (2004-0103) 2.7X250MM TRANSSACRAL BEV. TIP WIRE THD (2004-0141) 4.5X160MM DRILL SLEEVE (2004-0121) 2.70mm Guide Wire Thd Trocar Tip CoCr 300mm (2004-0023) 2.7X350MM TRANSSACRAL BEV. TIP WIRE THD (2004-0142) 2.70mm Guide Wire Drill Tip Cocr 450mm (2004-0024 2.70mm Guide Wire Drill Tip CoCr 300mm (2004-0101) 2.70mm Guide Wire Drill Tip CoCr 300mm (2004-0022) 4.5X100MM DRILL SLEEVE (2004-0122) 2.7X350MM TRANSSACRAL BEVELED TIP WIRE (2004-0102) 2.70mm Guide Wire THD Trocar Tip CoCr 450mm (2004-0025) 2.7X450MM TRANSSACRAL BEV. TIP WIRE THD (2004-0143)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)