BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    TIBIAL STEM TRIAL SZ 14mm x 75m (M-3212-1475)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    1

    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
    K210695

    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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    TIBIAL STEM TRIAL SZ 14mm x 75m (M-3212-1475) DISTAL FEMORAL CUT BLOCK (101-51005) Tibial Augment Trial Sz 0 5mm Left (M-3212-4005-L) M-3311-4040 Tibial Augment Trial Sz 2 5mm Right (M-3212-4205-R) Tibial Augment Trial Sz 5 5mm Left (M-3212-4505-L) M-3311-2020 Tibial Augment Trial Sz 0 5mm Right (M-3212-4005-R) M-3311-4030 Tibial Augment Trial Sz 2 5mm Left (M-3212-4205-L) 12MM Tibial Stem Drill (101-52050) Tibial Augment Trial Sz 5 5mm Right (M-3212-4505-R) M-3311-2050 Curved Osteotome (101-51061) Tibial Augment Trial Sz 1 5mm Right (M-3212-4105-R) M-3311-4050 M-3311-2010 M-3311-2030 PIN PULLER (101-51055) M-3311-4020 Tibial Stem Drill 12mm Bushing (101-52043) M-3311-4010 M-3311-2040 FEMORAL IM ROD (101-51001) Tibial Augment Trial Sz 1 5mm Left (M-3212-4105-L)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)