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    FDA Registration Active 🇲🇾 Malaysia

    Mini Clamp Jam Nut (71062016) Mini Double Pin Clamp with Ball Joint (81011771/0)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    18
    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
    K040656

    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

    Proprietary Names

    Mini Clamp Jam Nut (71062016) Mini Double Pin Clamp with Ball Joint (81011771/0) Pull Pin (71062016 Mini Double Pin Clamp with Ball Joint (81011420/0) Knob Pin (71062016 Mini Double Pin Clamp with Ball Joint (81011421/0) Quick Clamp 10.5mm to 4mm (71067371) Quick Clamp 6mm to 5mm (71067380) Quick Clamp 6mm to 4mm (71067377) Quick Clamp 6mm to 6mm (71067378) Quick Clamp 10.5mm to 5mm (71067372) Quick Clamp 10.5mm to 10.5mm (71067374) 6 Hole Pin Clamp (71067376) Pivot Axle (81014002) Ankle Clamp Bolt (81015393) DART-FIRE™ COMPRESSION SCREW HEADED SCREW 3.5MM X 58MM (D1N35058S) Clamp Bolt-Small (81015394) Conversion Kit Clamp Assembly (81106483) Ankle Clamp Moving Jaw (81015391) Freedom Bolt Joint Clamp (71067382) 4 Hole Pin Clamp (71067375)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)