BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    DC2820020 TI LOCK SCREW 3.5 X [TAB] DARCO® SYSTEM

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    89
    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
    K061808

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    DC2820020 TI LOCK SCREW 3.5 X [TAB] DARCO® SYSTEM TI NON LOCK SCREW 2.7 X 26MM (DCS2825126) TI NON-LOCK SCREW 2.7 X 18MM (DC2825118) DC2820135 TI NON LOCK SCREW 3.5 X 35MM TI LOCK SCREW 2.7 X 18MM (DC2825018) TI LOCK SCREW 2.7 X 26MM (DCS2825026) TI LOCK SCREW 2.7 X 12MM (DCS2825012) TI NON LOCK SCREW 2.7 X 20MM (DCS2825120) TI NON-LOCK SCREW 2.7 X 20MM (DCS2825120) DC2822038 DARCO® CANNULATED SCREW 3.5MM X [TAB] TI LOCK SCREW 2.7 X 8MM (DCS2825008) TI NON-LOCK SCREW 2.7 X 20MM (DC2825120) 136902 DARCO® CANNULATED SCREW 3.5MM X [TAB] TI NON-LOCK SCREW 2.7 X 14MM (DC2825114) TI NON-LOCK SCREW 2.7 X 26MM (DCS2825126) TI NON LOCK SCREW 3.5 X 14MM (DCS2820114) TI NON LOCK SCREW 2.7 X 22MM (DCS2825122) TI LOCK SCREW 2.7 X 16MM (DCS2825016) TI NON LOCK SCREW 2.7 X 10MM (DCS2825110) TI NON-LOCK SCREW 2.7 X 18MM (DCS2825118) TI NON LOCK SCREW 3.5 X 26MM (DC2820126) TI NON LOCK SCREW 3.5 X 40MM (DC2820140) TI NON LOCK SCREW 3.5 X 30MM (DCS2820130) TI LOCK SCREW 2.7 X 10MM (DC2825010) TI NON-LOCK SCREW 2.7 X 24MM (DCS2825124) DC2820114 TI NON LOCK SCREW 3.5 X 14MM DC2820120 TI NON LOCK SCREW 3.5 X 20MM 136091 DARCO® CANNULATED SCREW 3.5MM X [TAB] TI NON-LOCK SCREW 2.7 X 22MM (DC2825122) TI NON-LOCK SCREW 2.7 X 26MM (DC2825126) DC2822036 DARCO® CANNULATED SCREW 3.5MM X [TAB] TI NON-LOCK SCREW 2.7 X 10MM (DC2825110) TI LOCK SCREW 2.7 X 30MM (DC2825030) TI LOCK SCREW 2.7 X 20MM (DC2825020) TI LOCK SCREW 2.7 X 12MM (DC2825012) TI LOCK SCREW 2.7 X 28MM (DCS2825028) TI LOCK SCREW 2.7 X 22MM (DC2825022) TI LOCK SCREW 2.7 X 28MM (DC2825028) TI NON LOCK SCREW 3.5 X 24MM (DC2820124) TI NON LOCK SCREW 3.5 X 18MM (DC2820118) TI NON LOCK SCREW 3.5 X 28MM (DCS2820128) DC2820124 TI NON LOCK SCREW 3.5 X 24MM TI LOCK SCREW 2.7 X 8MM (DC2825008) TI LOCK SCREW 2.7 X 18MM (DCS2825018) TI LOCK SCREW 2.7 X 24MM (DCS2825024) TI NON-LOCK SCREW 2.7 X 16MM (DC2825116) TI NON-LOCK SCREW 2.7 X 8MM (DC2825108) TI LOCK SCREW 2.7 X 10MM (DCS2825010) TI LOCK SCREW 2.7 X 20MM (DCS2825020) DC2820128 TI NON LOCK SCREW 3.5 X 28MM DC2820122 TI NON LOCK SCREW 3.5 X 22MM TI NON LOCK SCREW 3.5 X 16MM (DCS2820116) DC2820126 TI NON LOCK SCREW 3.5 X 26MM 136204 TI LOCK SCREW 3.5 X [TAB] DARCO® SYSTEM TI NON LOCK SCREW 2.7 X 18MM (DCS2825118) TI NON LOCK SCREW 3.5 X 30MM (DC2820130) TI LOCK SCREW 2.7 X 30MM (DCS2825030) TI NON LOCK SCREW 3.5 X 28MM (DC2820128) TI NON LOCK SCREW 2.7 X 8MM (DCS2825108) TI NON LOCK SCREW 3.5 X 35MM (DC2820135) TI NON-LOCK SCREW 2.7 X 28MM (DC2825128) DC2820118 TI NON LOCK SCREW 3.5 X 18MM 136090 DARCO® CANNULATED SCREW 3.5MM X [TAB] TI NON LOCK SCREW 2.7 X 12MM (DCS2825112) TI NON LOCK SCREW 2.7 X 28MM (DCS2825128) TI NON LOCK SCREW 3.5 X 16MM (DC2820116) DC2820116 TI NON LOCK SCREW 3.5 X 16MM DC2820140 TI NON LOCK SCREW 3.5 X 40MM TI LOCK SCREW 2.7 X 14MM (DCS2825014) TI NON LOCK SCREW 3.5 X 22MM (DC2820122) DC2820130 TI NON LOCK SCREW 3.5 X 30MM TI NON LOCK SCREW 2.7 X 30MM (DC2825130) TI NON LOCK SCREW 2.7 X 16MM (DCS2825116) TI NON LOCK SCREW 3.5 X 40MM (DCS2820140) TI NON-LOCK SCREW 2.7 X 24MM (DC2825124) TI NON LOCK SCREW 3.5 X 35MM (DCS2820135) TI NON-LOCK SCREW 2.7 X 12MM (DC2825112) TI NON LOCK SCREW 2.7 X 30MM (DCS2825130) DC2822034 DARCO® CANNULATED SCREW 3.5MM X [TAB] TI LOCK SCREW 2.7 X 16MM (DC2825016) TI LOCK SCREW 2.7 X 14MM (DC2825014) TI NON LOCK SCREW 3.5 X 14MM (DC2820114) TI LOCK SCREW 2.7 X 22MM (DCS2825022) TI NON LOCK SCREW 2.7 X 24MM (DCS2825124) TI NON LOCK SCREW 2.7 X 14MM (DCS2825114) TI LOCK SCREW 2.7 X 24MM (DC2825024) TI NON LOCK SCREW 3.5 X 20MM (DC2820120) TI NON-LOCK SCREW 2.7 X 22MM (DCS2825122) TI LOCK SCREW 2.7 X 26MM (DC2825026)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)