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    FDA Registration Active 🇲🇾 Malaysia

    Empowr PS Knee™ Condyle Captured Box Guide Sizes 10 (80005077)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    19
    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
    K160342

    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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    Empowr PS Knee™ Condyle Captured Box Guide Sizes 10 (80005077) Empowr PS Knee™ Uncaptured Box Guide Sizes 5 (800-05-044) Empowr PS Knee™ Condyle Captured Box Guide Sizes 9 (800-05-076) Empowr PS Knee™ Uncaptured Box Guide Sizes 9 (800-05-048) Empowr PS Knee™ Condyle Captured Box Guide Sizes 4 (800-05-071) Empowr PS Knee™ Uncaptured Box Guide Sizes 8 (800-05-047) Empowr PS Knee™ Condyle Captured Box Guide Sizes 5 (800-05-072) Empowr PS Knee™ Condyle Captured Box Guide Sizes 8 (800-05-075) Empowr PS Knee™ Condyle Captured Box Guide Sizes 6 (800-05-073) Empowr PS Knee™ Condyle Captured Box Guide Sizes 11 (80005078) Empowr PS Knee™ Uncaptured Box Guide Sizes 2 (800-05-041) Empowr PS Knee™ Uncaptured Box Guide Sizes 3 (800-05-042) Empowr PS Knee™ Uncaptured Box Guide Sizes 4 (800-05-043) Empowr PS Knee™ Uncaptured Box Guide Sizes 6 (800-05-045) Empowr PS Knee™ Uncaptured Box Guide Sizes 7 (800-05-046) Empowr PS Knee™ Uncaptured Box Guide Sizes 10 (800-05-049) Empowr PS Knee™ Condyle Captured Box Guide Sizes 7 (800-05-074) INS, KNEE, EMPOWR, Tibial Template/Baseplate Impactor, LL (801-06-019) INSTRUMENT, KNEE, EMPOWR, Proximal Tibial Sizer, LL (801-06-017)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)