BEUDAMED
    FDA Registration Active 🇮🇳 India

    Latitude™ Hip Replacement System (Triad Acetabular Cup System & Proximally coated un-cemented femoral stem)

    Reg #: 3018052045 · FEI: 3018052045 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AKSHAR GAMMA STERILES LLP
    Registration Number
    3018052045
    FEI Number
    3018052045
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,
    City
    THANE Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K183532

    Owner / Operator

    Firm Name
    AKSHAR GAMMA STERILES LLP
    Operator Number
    10084053
    Address
    PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,
    City
    THANE
    State
    Maharashtra
    Postal Code
    421506
    Country
    IN

    US Agent

    Business Name
    Liberty Management Group Ltd.
    Contact Name
    Manoj Zacharias
    Address
    75 Executive Drive,, Suite 114,
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    Latitude™ Hip Replacement System (Triad Acetabular Cup System & Proximally coated un-cemented femoral stem)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)