BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    BLACKHAWK TI,INSERTER,MAIN CORE V2 (T070-0001-A3)

    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
    K223869

    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
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    BLACKHAWK TI,INSERTER,MAIN CORE V2 (T070-0001-A3) BLACKHAWK TI,LOADING BLOCK (T070-0005) BLACKHAWK TI,INNER SHAFT,INSERTER (T070-0001-02) 14 X 16 X 6 Trial Lordotic Universal (05-099-05-1606) BLACKHAWK TI,INSERTER,DEPLOY SUBASSEMBLY (T070-0001-A1) 12 X 14 X 8 Trial Lordotic Universal (05-099-05-1408) 14 X 16 X 7 Trial Lordotic Universal (05-099-05-1607) BLACKHAWK TI,GRAFT IMPACTOR (T070-0006) 12 X 14 X 10 Trial Lordotic Universal (05-099-05-1410) 12 X 14 X 9 Trial Lordotic Universal (05-099-05-1409) 14 X 16 X 8 Trial Lordotic Universal (05-099-05-1608) Rasp with Silicone Handle Blackhawk (05-099-10-0000) BLACKHAWK TI,CAM DRIVER,V2 (T070-0018) 12 X 14 X 7 Trial Lordotic Universal (05-099-05-1407) BLACKHAWK TI,REMOVAL TOOL (T070-0004) 14 X 16 X 9 Trial Lordotic Universal (05-099-05-1609) 14 X 16 X 10 Trial Lordotic Universal (05-099-05-1610) BLACKHAWK TI,DRAW ROD DRIVER,INSERTER (T070-0001-07) BLACKHAWK TI,SINGLE ANCHOR DEPLOY ARM (T070-0017) 12 X 14 X 6 Trial Lordotic Universal (05-099-05-1406)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)