BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Universal Plate Bender (01-SF18)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    2

    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
    K223118

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    Universal Plate Bender (01-SF18) OLEC-06108L OLEC-10152L OLEC-06108R T15 X 110mm Quick Connect Driver (01-T15110) 2.8mm X 155mm Drill Bit (Calibrated) (DR28-155C) OLEC-03078R OLEC-03078L Right Pmpt Plate 6 Hole X 91mm (PMPT-06091R) 01-T08085 T8 Quick Connect Drive 2.8mm X 200mm Drill Bit (Calibrated) (DR28-200OIC) 3.5mm Lag Drill (DR35-110) DR18-110 Diameter 1.8mm X 110mm Drill Bit 2.8mm Thread-In Drill Guide (LG-0028) Right Lpt Plate 4 Hole X 75mm (LPT-04075R) Left MDT Plate 6 Hole x 127mm (MDT-06127L) Left Lpt Plate 4 Hole X 75mm (LPT-04075L) Right MDT Plate 13 Hole x 214mm (MDT-13214R)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)