BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Smart FX Acute Adjustment Band (81107215)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    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
    K221792

    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
    Software For Diagnosis/Treatment OSN
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Smart FX Acute Adjustment Band (81107215) Acute QC Strut - Short (81115597) Acute Adjustment Button (81107220) Acute QC Strut - Long (81115221) Gripper (1450195) Acute QC Strut - XShort (81115599) Acute QC Strut Body-Short (81115601) Speed Nut (81115587) HA Half Pin Washer (2mm) 81116135 HA Half Pin Washer (4mm) 81116136 Acute QC Strut - Medium (81115595) Acute QC Strut Body - XShort (81115602) Acute Qc Strut Body - Long (81115222)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)