BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ZAV-1255-09 (18X16 Sizer. 10 deg. 5 & 6 mm)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    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
    K143228

    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, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    ZAV-1255-09 (18X16 Sizer. 10 deg. 5 & 6 mm) ZAV-1255-10 (18X16 Sizer. 10 deg. 7 & 8 mm) ZAV-1255-06 (16X14 Sizer. 10 deg. 7 & 8 mm) ZAV-1255-11 (18X16 Sizer. 10 deg. 9 & 10 mm) ZAV-1255-07 (16X14 Sizer. 10 deg. 9 & 10 mm) ZAV-1255-05 (16X14 Sizer. 10 deg. 5 & 6 mm)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)