BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    3.5mm X 32mm Cannulated Screw Self Drill - Tap (OS326932-T)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    3

    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
    K141784

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Plate, Fixation, Bone HRS

    Proprietary Names

    3.5mm X 32mm Cannulated Screw Self Drill - Tap (OS326932-T) Drill/Countersink Combo QC-4 Cannulated Screw (OS200400) Convex Reamer, 18mm (OS200518) 3.5mm X 40mm Cannulated Screw Self Drill - Tap (OS326940-T) Countersink 4mm Headless Cannulated Screw (OS200401) 3.5mm X 25mm Cannulated Screw Self Drill - Tap (OS326925-T) Countersink 3.5mm Headed Cannulated Screw (OS328017) 3.5mm Locking Screw 22mm (OS421722) T10 Torx Driver Shaft Cannulated Qc (OS328028C) 3.5mm X 36mm Cannulated Screw Self Drill - Tap (OS326936-T) Lapidus Plate 0mm - Right (R421000R) Lapidus Plate 0mm - Left (R421000L) 3.5mm X 28mm Cannulated Screw Self Drill - Tap (OS326928-T) 3.5mm X 60mm Cannulated Screw Self Drill - Tap (OS326960-T) 3.5mm X 22mm Cannulated Screw Self Drill - Tap (OS326922-T) Mtp Plate Medium Right (OS42260MR) 3.5mm X 55mm Cannulated Screw Self Drill - Tap (OS326955-T) 3.5mm X 24mm Cannulated Screw Self Drill - Tap (OS326924-T) 3.5mm X 45mm Cannulated Screw Self Drill - Tap (OS326945-T) 3.5mm X 34mm Cannulated Screw Self Drill - Tap (OS326934-T) 3.5mm X 26mm Cannulated Screw Self Drill - Tap (OS326926-T) 3.5mm X 38mm Cannulated Screw Self Drill - Tap (OS326938-T) Convex Reamer, 16mm (OS200516) 3.5mm X 30mm Cannulated Screw Self Drill - Tap (OS326930-T) 3.5mm X 20mm Cannulated Screw Self Drill - Tap (OS326920-T) Convex Reamer 22mm (OS200522) 3.5mm Locking Screw 24mm (R421724) Convex Reamer 20mm (OS200520) 3.5mm X 50mm Cannulated Screw Self Drill - Tap (OS326950-T)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)