BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    MODE, Nail, 125Deg, 10mm Diameter, 15cm, SFP (783-1-11015)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    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
    K211086

    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
    Rod, Fixation, Intramedullary And Accessories HSB
    Nail, Fixation, Bone JDS

    Proprietary Names

    MODE, Nail, 125Deg, 10mm Diameter, 15cm, SFP (783-1-11015) Troch Nail Lag End Cap Exterior Sleeve Driver, SFP (880-1-10343) Distal Drill Sleeve (881-1-10450) Troch Nail, Lag Screw Driver, SFP (880-1-10240) MODE, Nail, 130Deg, 13mm Diameter, 17cm, SFP (782-1-11317) Alignment Guide, SFP (880-1-10200) Sagittal Screw Sleeve, SFP (880-1-10411) Troch Nail, 125°, 10mm Diameter, 28cm, Left (783-1-11028-01L)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)