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    FDA Registration Active 🇲🇾 Malaysia

    20mm Straight Narrow Bender (MDL-100-108-02-20S)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    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
    K200301

    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
    Anterior Staple As Supplemental Fixation For Fusion PHQ

    Proprietary Names

    20mm Straight Narrow Bender (MDL-100-108-02-20S) Drill, Long per MDL-100-106-167 G ACDF Drill Bit, 12mm Long 01-106-12L Fixation Pin per MDL-100-105-02 C ACDF Wide Bender, 20mm Angled 01-108-20A ACDF Wide Bender, 18mm Angled 01-108-18A ACDF Wide Bender, 14mm Straight 01-107-14S Locking Pin per MDL-100-108-04 B 20mm Straight Wide Bender (MDL-100-108-01-20S) Drill, Short per MDL-100-106-141 G ACDF Wide Bender, 20mm Straight 01-107-20S ACDF Wide Bender, 16mm Angled 01-108-16A ACDF Locking Pin 01-113 ACDF Narrow Bender, 20mm Angled 01-111-20A ACDF Drill Bit, 12mm Short 01-106-12S ACDF Narrow Bender, 20mm Straight 01-110-20S ACDF Narrow Bender, 16mm Straight 01-110-16S ACDF Narrow Bender, 14mm Angled 01-111-14A ACDF Narrow Bender, 16mm Angled 01-111-16A ACDF Wide Bender, 18mm Straight 01-107-18S ACDF Narrow Bender, 14mm Straight 01-110-14S ACDF Fixation Pin 01-105 ACDF Narrow Bender, 18mm Straight 01-110-18S ACDF Wide Bender, 14mm Angled 01-108-14A ACDF Wide Bender, 16mm Straight 01-107-16S ACDF Narrow Bender, 18mm Angled 01-111-18A

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)