BEUDAMED
    FDA Registration Active 🇮🇳 India

    Strut Small

    Reg #: 3013747584 · FEI: 3013747584 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    S.H.PITKAR ORTHOTOOLS PVT. LTD.
    Registration Number
    3013747584
    FEI Number
    3013747584
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EL 32, J Block, MIDC Bhosari, Pune
    City
    Pune Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K200728

    Owner / Operator

    Firm Name
    S.H.Pitkar Orthotools Pvt. Ltd.
    Operator Number
    10087372
    Address
    EL 32, J Block,, MIDC Bhosari
    City
    Pune
    State
    Maharashtra
    Postal Code
    411026
    Country
    IN
    Correspondent
    Vivek Mangalwedhekar

    US Agent

    Business Name
    Premkumar Reddy Medical, USA LLC
    Contact Name
    Premkumar Babu
    Address
    808 Independence Dr
    City
    Harleysville
    State
    PA
    ZIP
    19438
    Country
    US
    Email
    [email protected]
    Phone
    208 8616488

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Software For Diagnosis/Treatment OSN

    Proprietary Names

    Strut Small C Plate for SS Ring Y - Connector Aluminium Ring Labels For Strut Y Connector SS Ring X Ray Marker for Strut C Plate for Aluminium Ring Strut Large Strut Medium

    Establishment Types

    Manufacture Medical Device