BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Empowr Acet DM, Head Trial, Threaded Offset Sleeve, 0mm (803-15-112)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    21
    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
    K203557

    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, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Empowr Acet DM, Head Trial, Threaded Offset Sleeve, 0mm (803-15-112) Empowr Acetabular DM, Thread Head Trial, 54mm (803-15-154) Empowr Acetabular DM, Thread Head Trial, 44mm (803-15-144) Empowr Acetabular DM, Thread Head Trial, 38mm (803-15-138) Empowr Acetabular DM, Thread Head Trial, 42mm (803-15-142) Empowr Acet DM, Threaded Head Trial, 40mm (803-15-140) 803-15-258 (Empowr Acet DM, Dual Art Head Trial, Slotted 58mm) Empowr Acet DM, Head Trial, Threaded Offset Sleeve, +7mm (803-15-114) Empowr Acet DM, Head Trial, Threaded Offset Sleeve, -3.5mm (803-15-111) Empowr Acet DM, Head Trial, Threaded Offset Sleeve, +10.5mm (803-15-115) Empowr Acetabular DM, Thread Head Trial, 50mm (803-15-150) Empowr Acetabular DM, Thread Head Trial, 46mm (803-15-146) Empowr Acet DM, Head Trial, Threaded Offset Sleeve, +3.5mm (803-15-113) 803-15-238 (Empowr Acet DM, Dual Art Head Trial, Slotted 38mm) Empowr Acetabular DM, Thread Head Trial, 58mm (803-15-158) 803-15-250 (Empowr Acet DM, Dual Art Head Trial, Slotted 50mm) 803-15-240 (Empowr Acet DM, Dual Art Head Trial, Slotted 40mm) 803-15-244 (Empowr Acet DM, Dual Art Head Trial, Slotted 44mm) 803-15-246 (Empowr Acet DM, Dual Art Head Trial, Slotted 46mm) 803-15-254 (Empowr Acet DM, Dual Art Head Trial, Slotted 54mm) 803-15-242 (Empowr Acet DM, Dual Art Head Trial, Slotted 42mm)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)