BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    7 Drill for 12 Screw (NV70-QD12)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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
    K182721

    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
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    7 Drill for 12 Screw (NV70-QD12) NV70-Q007 NVL Triton T50 Driver V2, Navigation Nvl, Triton Drill, Navigation (NV70-QD08) Nvl, Triton Drill, Navigation (NV70-QD12) NV70-QT08, NV70-QT12, NV70-QT14 NVL, Tiron Tap, Navigation Nvl, Triton Tap, Navigation (NV70-QT14) NV70-QD08, NV70-QD12, NV70-QD14 NVL, Tiron Drill, Navigation 4 Drill for 8 Screw (NV70-QD08) Nvl Triton T50 Driver V2, Navigation (NV70-Q007) Nvl, Triton Tap, Navigation (NV70-QT12) 9 Drill for 14 Screw (NV70-QD14) 7 Drill for 8 Screw (NV70-QT08) Nvl, Triton Drill, Navigation (NV70-QD14) Nvl, Triton Tap, Navigation (NV70-QT08) 11 Drill for 12 Screw (NV70-QT12) 13 Drill for14 Screw (NV70-QT14)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)