BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ADJUSTABLE HUMERAL GUIDE IN-22500-001

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3025603301
    FEI Number
    3025603301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1264, Lorong PSPN 1, Penang Science Park North
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K243950

    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
    Orthopedic Augmented Reality SBF
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    ADJUSTABLE HUMERAL GUIDE IN-22500-001 TRACKER B, MECHANICAL IN-22600-001 Resection Guide Alignment Paddle IN-28100-001 ADJUSTABLE BONE MOUNT IN-28070-001 ANATOMIC GUIDE TIP, LARGE IN-23200-001 ANATOMIC ROTATION GUIDE IN-26100-001 3.5mm Hex Driver, LL IN-10800-001 ANATOMIC GUIDE TIP, SMALL IN-23100-001 STEM ADAPTER IN-22800-001 STRAIGHT REAMER ADAPTER IN-22400-001 Mechanical Tracker A IN-24000-001 WEDGE REAMER ADAPTER IN-22900-001 Reference Pin Guide IN-18500-001

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)