BEUDAMED
    FDA Registration Active 🇮🇳 India

    ProMIA Tower Screw Diameter 5.5mm, 6.5mm Length 30mm to 50mm

    Reg #: 3013747584 · FEI: 3013747584 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    3

    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
    K240233

    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, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    ProMIA Tower Screw Diameter 5.5mm, 6.5mm Length 30mm to 50mm Ti ProMIS Spinal Straight Rod Diameter 5.5mm Length 120mm to 300mm Ti Elliac Connector Length 20mm, 30mm 40mm, 60mm Ti Uniloc Pedicle Reduction Screw Diameter 4.5mm, 5.5mm, 6.5mm Length 30mm to 50mm Ti Combi Spinal Rod Diameter 3.3mm Length 500 mm Ti Unistar Poly Reduction Screw Diameter 4.5mm, 5.5mm, 6.5mm Length 30mm to 50mm Ti V Locx Poly Screw Diameter 5.5mm, 6.5mm Length 3mm to 50mm Ti Uniloc D Connector Ti Unistar Pedicle Screw Diameter 4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm Length 30mm to 50mm Ti ProMIS Poly Screw Diameter 5.5mm, 6.5mm Length 30mm to 50mm Ti Unistar Poly Pedicle Screw Diameter 4.5mm, 5.5mm, 6.5mm Length 30mm to 50mm Ti Uniloc Poly Reduction Screw Diameter 4.5mm, 5.5mm, 6.5mm 7.5mm Length 30mm to 50mm Ti Unistar Pedicle Reduction Screw Diameter 4.5mm, 5.5mm, 6.5mm, 7.5mm Length 30mm to 50mm Ti Trigen Pedicle Screw Diameter 4.5mm, 5.5mm, 6.5mm Length 26mm to 50mm Ti Poly Elliac Screw Diameter 5.5mm, 6.5mm 7.5mm Length 60mm to 80mm Ti Uniloc Spinal Precut Rod Diameter 5.7mm Length 70mm to 500mm Ti Uniloc Poly Pedicle Screw Diameter 4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm Length 30mm to 50mm Ti Trigen Domino Connector Diameter 5.7mm Length 4.4mm Ti Uniloc Pedicle Screw Diameter 4.5mm, 5.5mm, 6.5mm, 7.5mm Length 30mm to 50mm Ti Uniloc D Connector Rod Diameter 4mm Length 75mm, 100mm, 125mm, 150mm Ti ProMIS Spinal Pre-Cut Rod Diameter 5.5mm Length 30mm to 200mm Ti V Locx Pedicle Screw Diameter 5.5mm, 6.5mm Length 35mm, 40mm, 45mm Ti Trigen Precut Rod Diameter 5.4mm Length 50mm to 500mm Ti Trigen Poly Reduction Screw Diameter 4.5mm, 5.5mm, 6.5mm Length 26mm to 50mm ProMIS Tower Dual Screw Diameter 5.5mm, 6.5mm Length 30mm to 50mm Ti Trigen Poly Screw Diameter 4.5mm, 5mm, 6mm, 7.5mm, 8.5mm Length 26mm to 50mm

    Establishment Types

    Manufacture Medical Device