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    FDA Registration Active 🇲🇾 Malaysia

    PROSTEP MICA SCREW 4MM X 42MM (57S04042)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    117
    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
    K162353

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    PROSTEP MICA SCREW 4MM X 42MM (57S04042) PROSTEP MICA SCREW 3MM X 40MM (57S03040) MICA SCREW 3MM X 32MM (57713032) PROSTEP MICA SCREW 3MM X 46MM (57S03046) MICA SCREW 4MM X 34MM (57734034) MICA SCREW 4MM X 24MM (57734024) PROSTEP MICA SCREW 3MM X 32MM (57S03032) PROSTEP MICA SCREW 3MM X 38MM (57S03038) MICA SCREW 3MM X 50MM (57S13050) PROSTEP MICA SCREW 4MM X 60MM (57S04060) PROSTEP MICA SCREW 3MM X 24MM (57S03024) PROSTEP MICA SCREW 3MM X 44MM (57S03044) MICA SCREW 3MM X 22MM (57713022) MICA SCREW 4MM X 36MM (57734036) PROSTEP MICA SCREW 4MM X 34MM (57S04034) PROSTEP MICA SCREW 3MM X 30MM (57S03030) PROSTEP MICA SCREW 3MM X 50MM (57S03050) MICA SCREW 4MM X 24MM (57S34024) MICA SCREW 4MM X 48MM (57S34048) MICA SCREW 4MM X 52MM (57734052) MICA SCREW 3MM X 26MM (57S13026) PROSTEP MICA SCREW 3MM X 28MM (57S03028) PROSTEP MICA SCREW 4MM X 28MM (57S04028) MICA SCREW 4MM X 20MM (57S34020) MICA SCREW 4MM X 36MM (57S34036) MICA SCREW 3MM X 20MM (57S13020) MICA SCREW 4MM X 58MM (57S34058) MICA SCREW 3MM X 42MM (57S13042) MICA SCREW 3MM X 36MM (57713036) PROSTEP MICA SCREW 4MM X 24MM (57S04024) MICA SCREW 4MM X 52MM (57S34052) MICA SCREW 3MM X 46MM (57713046) PROSTEP MICA SCREW 4MM X 20MM (57S04020) PROSTEP MICA SCREW 4MM X 48MM (57S04048) MICA SCREW 4MM X 38MM (57S34038) MICA SCREW 3MM X 28MM (57713028) MICA SCREW 3MM X 40MM (57713040) PROSTEP MICA SCREW 4MM X 22MM (57S04022) MICA SCREW 4MM X 44MM (57S34044) MICA SCREW 4MM X 40MM (57S34040) MICA SCREW 3MM X 24MM (57713024) PROSTEP MICA SCREW 4MM X 54MM (57S04054) MICA SCREW 3MM X 46MM (57S13046) PROSTEP MICA SCREW 4MM X 44MM (57S04044) MICA SCREW 3MM X 38MM (57S13038) MICA SCREW 3MM X 44MM (57713044) PROSTEP MICA SCREW 4MM X 32MM (57S04032) MICA SCREW 4MM X 50MM (57S34050) MICA SCREW 4MM X 34MM (57S34034) MICA SCREW 4MM X 50MM (57734050) MICA SCREW 4MM X 40MM (57734040) MICA SCREW 4MM X 30MM (57734030) MICA SCREW 4MM X 44MM (57734044) MICA SCREW 3MM X 44MM (57S13044) MICA SCREW 4MM X 54MM (57S34054) MICA SCREW 3MM X 48MM (57S13048) MICA SCREW 3MM X 20MM (57713020) MICA SCREW 3MM X 30MM (57713030) MICA SCREW 4MM X 32MM (57734032) PROSTEP MICA SCREW 3MM X 48MM (57S03048) PROSTEP MICA SCREW 4MM X 52MM (57S04052) PROSTEP MICA SCREW 4MM X 38MM (57S04038) MICA SCREW 4MM X 54MM (57734054) MICA SCREW 3MM X 36MM (57S13036) MICA SCREW 4MM X 22MM (57734022) MICA SCREW 4MM X 22MM (57S34022) MICA SCREW 4MM X 26MM (57734026) PROSTEP MICA SCREW 4MM X 40MM (57S04040) PROSTEP MICA SCREW 4MM X 58MM (57S04058) PROSTEP MICA SCREW 3MM X 26MM (57S03026) MICA SCREW 3MM X 30MM (57S13030) MICA SCREW 4MM X 46MM (57734046) MICA SCREW 3MM X 42MM (57713042) MICA SCREW 3MM X 34MM (57S13034) MICA SCREW 3MM X 28MM (57S13028) MICA SCREW 4MM X 20MM (57734020) MICA SCREW 3MM X 38MM (57713038) MICA SCREW 3MM X 24MM (57S13024) MICA SCREW 4MM X 32MM (57S34032) MICA SCREW 3MM X 34MM (57713034) MICA SCREW 4MM X 48MM (57734048) PROSTEP MICA SCREW 4MM X 50MM (57S04050) MICA SCREW 4MM X 28MM (57S34028) PROSTEP MICA SCREW 4MM X 30MM (57S04030) PROSTEP MICA SCREW 3MM X 22MM (57S03022) PROSTEP MICA SCREW 4MM X 26MM (57S04026) MICA SCREW 3MM X 32MM (57S13032) MICA SCREW 4MM X 46MM (57S34046) MICA SCREW 4MM X 42MM (57734042) MICA SCREW 3MM X 48MM (57713048) MICA SCREW 3MM X 50MM (57713050) PROSTEP MICA SCREW 4MM X 46MM (57S04046) MICA SCREW 3MM X 22MM (57S13022) PROSTEP MICA SCREW 3MM X 20MM (57S03020) MICA SCREW 4MM X 58MM (57734058) MICA SCREW 3MM X 26MM (57713026) PROSTEP MICA SCREW 4MM X 36MM (57S04036) PROSTEP MICA SCREW 3MM X 36MM (57S03036) MICA SCREW 4MM X 30MM (57S34030) MICA SCREW 4MM X 56MM (57S34056) MICA SCREW 4MM X 28MM (57734028) MICA SCREW 4MM X 38MM (57734038) MICA SCREW 3MM X 40MM (57S13040) MICA SCREW 4MM X 42MM (57S34042) MICA SCREW 4MM X 60MM (57734060) MICA SCREW 4MM X 56MM (57734056) PROSTEP MICA SCREW 3MM X 42MM (57S03042) MICA SCREW 4MM X 26MM (57S34026) MICA SCREW 4MM X 60MM (57S34060) PROSTEP MICA SCREW 4MM X 56MM (57S04056) PROSTEP MICA SCREW 3MM X 34MM (57S03034) Mica Screw 4mm x 38mm Fully Threaded Sterile (57S34038) Prostep Chamfer Screw 5x80mm Prostep Mis Lapidus System 57S05080 Mica Screw 4mm x 60mm Fully Threaded Sterile (57S34060) Mica Screw 3mm x 38mm Fully Threaded Sterile (57S13038) Mica Screw 4mm x 54mm Fully Threaded Sterile (57S34054) Mica Screw 3mm x 40mm Fully Threaded Sterile (57S13040)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)