BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Invision™ Talar Plate Size 3 Left Long (6300LP3L)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    1

    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
    K180730

    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, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN

    Proprietary Names

    Invision™ Talar Plate Size 3 Left Long (6300LP3L) Invision Talar Plate Size 4 Right Std (6300SP4R) Invision Locking Peg Size 18mm - 6300LP18 Invision Locking Peg Size 26mm - 6300LP26 Invision Talar Plate Size 4 Left Std (6300SP4L) Invision™ Talar Plate Size 1 Right Long (6300LP1R) Invision Locking Peg Size 10mm - 6300LP10 Invision Drill Guide Threaded - 63002001 Invision Central Peg 0mm - 6300CP00 2.8mm Drill Stryker Twist - 200028 Invision Peg Plate Impactor Radel Clip - 60006030 Invision Talar Plate Size 5 Right Std (6300SP5R) Invision™Talar Plate Size 5 Right Long ( 6300LP5R) Invision Locking Peg Size 24mm - 6300LP24 Invision Central Peg (6mm) - 6300CP06 Invision™ Talar Plate Size 1 Left Long (6300LP1L) 3.2mm Drill Stryker Twist - 200032 Invision™ Talar Plate Size 2 Right Long (6300LP2R) Invision ™ Talar Plate Size 4 Left Long (6300LP4L) Invision Locking Peg Size 14mm - 6300LP14 Invision Talar Peg Drill 3.8mm Central Stem - 63002005 Invision Locking Cap - 6300LP00 Invision Talar Plate Size 3 Right Std (6300SP3R) Invision Locking Peg Size 28mm - 6300LP28 Invision Locking Peg Size 20mm - 6300LP20 Invision Locking Peg Size 22mm - 6300LP22 Invision Talar Plate Size 2 Left Std (6300SP2L) Invision Talar Plate Size 1 Right Std (6300SP1R) Invision Talar Plate Size 3 Left Std (6300SP3L) Invision Central Peg (8mm) - 6300CP08 Invision™ Talar Plate Size 3 Right Long ( 6300LP3R) Invision™ Talar Plate Size 2 Left Long (6300LP2L) Invision Talar Plate Size 2 Right Std (6300SP2R) Invision™ Talar Plate Size 5 Left Long (6300LP5L) Invision™ Talar Plate Size 4 Right Long ( 6300LP4R) Invision Drill Guide Conical - 63002000 Invision Locking Peg Size 12mm - 6300LP12 Invision Locking Peg Size 16mm - 6300LP16 Invision Locking Peg Size 30mm - 6300LP30 Invision Talar Plate Size 5 Left Std (6300SP5L) Invision Talar Plate Size 1 Left Std (6300SP1L)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)