BEUDAMED
    FDA Registration Active 🇮🇳 India

    Titanium Locking Screw Self Tapping Diameter 2.7 mm Length 8 mm to 30 mm

    Reg #: 3013747584 · FEI: 3013747584 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    1

    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
    K192619

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    Titanium Locking Screw Self Tapping Diameter 2.7 mm Length 8 mm to 30 mm Titanium T3- Lox Distal Femur LCP 5mm LHS Right and Left Titanium T3- Lox Anterolateral Distal Tibia LCP 3.5mm LHS Right and Left Titanium Self Tapping Cortical Screw Diameter 2.7 mm Length 10 mm to 30 mm Titanium T3- Lox Medial Distal Tibia LCP 3.5mm LHS Right and Left Titanium T3- Lox Volar Distal Radius LCP Right and Left- Shaft 5 Holes Head 5 Holes 2.4mm LHS Titanium T3- Lox Distal Humerus LCP, Dorsolateral with Support Head 2.7/Shaft 3.5mm LHS Right and Left Titanium Self Tapping Cortical Screw Diameter 4.5 mm Length 14 mm to 80 mm Titanium T3- Lox Volar Buttress Distal Radius LCP Right and Left- Shaft 3 Holes Head 5 Holes 2.4mm LHS Titanium Cancellous Screw Fully Threaded Diameter 4 mm Length 10 mm to 60 mm Titanium T3- Lox Dorsal Distal Radius LCP Straight 2.4mm LHS- 5 and 6 Holes Titanium T3- Lox Medial Proximal Tibia LCP 3.5mm LHS Right and Left Titanium Locking Screw Self Tapping Diameter 2.4 mm Length 6 mm to 30 mm Titanium T3- Lox L Dorsal Distal Radius LCP Oblique, Right and Left Angled Shaft 3 and 4 Holes, Head 3 Holes, 2.4mm LHS Titanium T3- Lox Volar Distal Radius Extra-Articular LCP Right and Left, Shaft 3 and 5 Holes, Head 4 Holes 2.4mm LHS Titanium T3- Lox Distal Medial Humerus LCP Head 2.7/Shaft 3.5mm LHS Right and Left Titanium T3- Lox L Dorsal Distal Radius LCP, Right and Left Angled Shaft 3 and 4 Holes, Head 3 Holes, 2.4mm LHS Titanium T3- Lox L Dorsal Distal Radius LCP, Right and Left Angled Shaft 3 and 4 Holes, Head 2 Holes, 2.4mm LHS Titanium T3- Lox Distal Humerus LCP, Dorsolateral Head 2.7/ Shaft 3.5mm LHS Right and Left Titanium Self Tapping Cortical Screw Diameter 3.5 mm 20 TPI Length 10mm to 40 mm Titanium Locking Screw Self Tapping Diameter 5 mm Length 14 mm to 90 mm Superior Anterior Clavicle LCP 3.5mm LHS Right and Left- Holes 6, 7, 8 Titanium T3- Lox Volar Distal Radius LCP Right and Left- Shaft 3 Holes Head 5 Holes 2.4mm LHS Titanium Self Tapping Cortical Screw Diameter 2.4 mm Length 6mm to 30 mm Superior Anterior Clavicle LCP with Lateral Extension Head 2.7mm/ Shaft 3.5mm LHS Left and Right Titanium T3- Lox Proximal Humerus LCP 3.5mm LHS Titanium T3- Lox Volar Distal Radius Extra-Articular LCP Right and Left- Shaft 3 and 5 Holes, Head 5 Holes 2.4mm LHS Titanium T3- Lox Proximal Lateral Tibia LCP 5mm LHS Right and Left Titanium T3- Lox Distal Humerus LCP Extra-Articular 3.5mm LHS Right and Left Titanium Locking Screw Self Tapping Diameter 3.5 mm Length 10mm to 60 mm

    Establishment Types

    Manufacture Medical Device