BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Recon 2.7 mm Locking Screw 50 mm (TLR27-50)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3012217062
    FEI Number
    3012217062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
    City
    Perai Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K230204

    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
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    Recon 2.7 mm Locking Screw 50 mm (TLR27-50) Recon 2.7 mm Locking Screw 20 mm Recon 2.7 mm Locking Screw 22 mm (TLR27-22) Recon 2.7 mm Locking Screw 30 mm (TLR27-30) Recon 2.7 mm Locking Screw 38 mm (TLR27-38) Ankle FX 8mm Offset Hook Plate Inserter Assembly - TZ-INSERT-08 Recon 2.7 mm Locking Screw 34 mm (TLR27-34) Recon 2.7 mm Locking Screw 10 mm (TLR27-10) Recon 2.7 mm Locking Screw 32 mm (TLR27-) Recon 2.7 mm Locking Screw 20 mm (TLR27-20) Ankle 12.6mm Offset Hook Plate Inserter Assembly - TZ-INSERT-12 Recon 2.7 mm Locking Screw 40 mm (TLR27-40) Recon 2.7 mm Locking Screw 36 mm (TLR27-36) Ankle FX Inserter,Posterior Tibia Plate Assembly - TZ-INSERT-PT Recon 2.7 mm Locking Screw 28 mm (TLR27-28) Recon 2.7 mm Locking Screw 24 mm (TLR27-24) Ankle FX 8mm Offset Hook Plate Guide Assembly - TZ-GUIDE-08 Ankle 12.6mm Offset Hook Plate Guide Assembly - TZ-GUIDE-12 Recon 2.7 mm Locking Screw 26 mm (TLR27-26)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)