BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    4973514N EVOLVE™ EPS CORT SCRW 3.5X14MM

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    41
    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
    K102352

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    4973514N EVOLVE™ EPS CORT SCRW 3.5X14MM 4973532N EVOLVE™ EPS CORT SCRW 3.5X32MM 4973518N EVOLVE™ EPS CORT SCRW 3.5X18MM 4973516N EVOLVE™ EPS CORT SCRW 3.5X16MM 4973524N EVOLVE™ EPS CORT SCRW 3.5X24MM 4972722N EVOLVE™ EPS CORT SCRW 2.7X22MM 4973534N Evolve ® EPS Cort Scrw 3.5 x 1.338 Non Locking 4972714N EVOLVE™ EPS CORT SCRW 2.7X14MM 4983555N Evolve® EPS Can Scrw 3.5 X 55mm Non Locking 4973560N EVOLVE™ EPS CORT SCRW 3.5X60MM 4983522N EVOLVE™ EPS CAN SCRW 3.5X22MM 4972740N EVOLVE™ EPS CORT SCRW 2.7X40MM 4972728N EVOLVE™ EPS CORT SCRW 2.7X28MM 4972716N EVOLVE™ EPS CORT SCRW 2.7X16MM 4973512N Evolve ® EPS Cort Scrw 3.5 x 0.472 Non Locking 4973522N EVOLVE™ EPS CORT SCRW 3.5X22MM 4983520N Evolve® EPS Can Scrw 3.5 X 20mm Non Locking 4983516N EVOLVE™ EPS CAN SCRW 3.5X16MM 4983550N EVOLVE™ EPS CAN SCRW 3.5X50MM 4972724N EVOLVE™ EPS CORT SCRW 2.7X24MM 4973526N EVOLVE™ EPS CORT SCRW 3.5X26MM 4972736N EVOLVE™ EPS CORT SCRW 2.7X36MM 4972726N EVOLVE™ EPS CORT SCRW 2.7X26MM 4972720N EVOLVE™ EPS CORT SCRW 2.7X20MM 4972750N EVOLVE™ EPS CORT SCRW 2.7X50MM 4972718N EVOLVE™ EPS CORT SCRW 2.7X18MM 4983532N EVOLVE™ EPS CAN SCRW 3.5X32MM 4973520N EVOLVE™ EPS CORT SCRW 3.5X20MM 4973528N EVOLVE™ EPS CORT SCRW 3.5X28MM 4973530N EVOLVE™ EPS CORT SCRW 3.5X30MM 4973555N EVOLVE™ EPS CORT SCRW 3.5X55MM 4983534N Evolve® EPS Can Scrw 3.5 X 34mm Non Locking 4973510N Evolve ® EPS Cort Scrw 3.5 x 0.394 Non Locking 4972745N Evolve ® EPS Cort Scrw 2.7 x 1.772 Non Locking Evolve ® EPS Cort Scrw 2.7 x 0.394 Non Locking (4972710N) 4983524N Evolve® EPS Can Scrw 3.5 X 24mm Non Locking 4973545N Evolve ® EPS Cort Scrw 3.5 x 1.772 Non Locking 4983538N Evolve ® EPS Can Scrw 3.5 x 38mm Non Locking 4973536N Evolve ® EPS Cort Scrw 3.5 x 1.417 Non Locking 4983518N Evolve® EPS Can Scrw 3.5 X 18mm Non Locking 4973538N Evolve ® EPS Cort Scrw 3.5 x 1.496 Non Locking

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)