BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Trial - Foundation 3D Plif - 30mm X 10mm X 14mm, 7° 02P01351

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    62
    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
    K162496

    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 Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Trial - Foundation 3D Plif - 30mm X 10mm X 14mm, 7° 02P01351 Trial - Foundation 3D Plif - 22mm X 10mm X 12mm, 7° 02P01139 Trial - Foundation 3D Plif - 26mm X 10mm X 14mm, 7° 02P01231 Plif Trial - 12mm X30mm 02P00100 Trial - Foundation 3D Plif - 22mm X 10mm X 15mm, 7° 02P01142 Plif Trial -11mm X 22mm 02P00083 Plif Trial - 8mm X 30mm 02P00096 F3D Straight 3PD Lumbar Trial - 26mm X 10mm X 9mm 12° 02P02910 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 8mm 12° 02P02902 Trial - Foundation 3D Plif - 26mm X 10mm X 12mm, 7° 02P01229 Trial - Foundation 3D Plif - 30mm X 10mm X 11mm, 7° 02P01348 Trial - Foundation 3D Plif - 30mm X 10mm X 10mm, 7° 02P01347 Plif Trial - 11mm X 26mm 02P00091 Tamp - Straight Plif 07P00010 Plif Trial -12mm X 22mm 02P00084 Trial - Foundation 3D Plif - 30mm X 10mm X 13mm, 7° 02P01350 Plif Trial - 9mm X 26mm 02P00089 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 13mm 12° 02P02907 Plif Trial - 8mm X 26mm 02P00088 Plif Trial -14mm X 22mm 02P00086 Trial - Foundation 3D Plif - 22mm X 10mm X 10mm, 7° 02P01137 Plif Trial - 11mm X30mm 02P00099 Plif Trial -13mm X 22mm 02P00085 Plif Trial - 9mm X30mm 02P00097 Plif Trial - 14mm X 26mm 02P00094 Trial - Foundation 3D Plif - 22mm X 10mm X 13mm, 7° 02P01140 Inserter - Plif 01P00007 Trial - Foundation 3D Plif - 30mm X 10mm X 15mm, 7° 02P01352 T-Handle, Hudson 15G00002, 15G00004 Plif Trial -12mm X 26mm 02P00092 Trial - Foundation 3D Plif - 22mm X 10mm X 8mm, 7° 02P01135 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 14mm 12° 02P02908 Trial - Foundation 3D Plif - 26mm X 10mm X 15mm, 7° 02P01232 Trial - Foundation 3D Plif - 26mm X 10mm X 13mm, 7° 02P01230 Trial - Foundation 3D Plif - 26mm X 10mm X 9mm, 7° 02P01226 Plif Trial -15mm X 22mm 02P00087 Plif Trial -10mm X 22mm 02P00082 Trial - Foundation 3D Plif - 26mm X 10mm X 11mm, 7° 02P01228 Plif Trial - 13mm X30mm 02P00101 Trial - Foundation 3D Plif - 22mm X 10mm X 9mm, 7° 02P01136 Plif Trial - 14mm X30mm 02P00102 Trial - Foundation 3D Plif - 26mm X 10mm X 8mm, 7° 02P01225 Plif Trial -10mm X30mm 02P00098 Plif Trial - 8mm X 22mm 02P00080 Trial - Foundation 3D Plif - 26mm X 10mm X 10mm, 7° 02P01227 Trial - Foundation 3D Plif - 30mm X 10mm X 8mm, 7° 02P01345 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 9mm 12° 02P02903 Plif Trial - 10mm X 26mm 02P00090 Inserter - Plif Slide Hammer Attachment 01P00013 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 12mm 12° 02P02906 Plif Trial -9mm X 22mm 02P00081 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 11mm 12° 02P02905 Trial - Foundation 3D Plif - 22mm X 10mm X 11mm, 7° 02P01138 Trial - Foundation 3D Plif - 30mm X 10mm X 12mm, 7° 02P01349 Trial - Foundation 3D Plif - 22mm X 10mm X 14mm, 7° 02P01141 Trial - Foundation 3D Plif - 30mm X 10mm X 9mm, 7° 02P01346 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 10mm 12° 02P02904 Slide Hammer 08G00003 Plif Trial - 15mm X 26mm 02P00095 Plif Trial - 15mm X30mm 02P00103 Plif Trial - 13mm X 26mm 02P00093 F3D Straight 3PD Lumbar Trial - 22mm X 10mm X 15mm 12° 02P02909

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)