BEUDAMED
    FDA Registration Active 🇮🇳 India

    Drill Guide: Sliding

    Reg #: 3014938863 · FEI: 3014938863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
    Registration Number
    3014938863
    FEI Number
    3014938863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit No.12, Electronic Co-operative Estate, Pune - Satara Road
    City
    Pune Maharashtra
    Country
    IN

    Owner / Operator

    Firm Name
    Indius Medical Technologies Pvt. Ltd.
    Operator Number
    10058793
    Address
    Unit 12, Floors 1 and 2, Electronic Co-operative Estate, Pune - Satara Road
    City
    Pune
    State
    Maharashtra
    Postal Code
    411009
    Country
    IN

    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
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Drill Guide: Sliding Locking Cap Guide NT In Situ Distraction device Tower Clip Reducer (wire cut) Vice Grip Torque limiting quick connect T handle (5_5 Nm) Locking Cap Guide Rod Inserter, Flexible Rod Lever Angled Reducer Extension Tube Candle Stick Overhead reducer NT Ratchetting Reducer Tower Reducer Vertebral body cavity creation instrument, small Rotational Quick Connect Handle Third Dilator Lateral Reducer Orthopedic manual surgical instrument Overhead reducer Parallel Distractor (non ratcheting) Parallel Distractor Clamp (Spine Retractor) Rod Calliper Lamina Finder Ratcheting quick connect straight handle Tower Reducer NT Long Trocar Tab Breaker Counter Torque, Cannulated Screw Straight Cannulated Ratchetting Handle Parallel Distractor - long throw Cross Connector Inserter K wire Pin Cement Delivery Cannula Anti-Splay Sleeve Torque limiting quick connect T handle (8 Nm) Ratchetting Reducer NT C-C Derotator Connection: Long Self-Retaining Sleeve M-L Derotator Connection: Long Rod Inserter, Separate incision Vertebral body cavity creation instrument, large Tower Reducer Sleeve Tower Reducer Shaft M-L Derotator Connection: Short Plunger Alignment Instrument: Prongs Holder: Inner Shaft Assembly Transverse Process Finder Cross Connector Calliper Long tab remover M-L Derotator Connection Long sleeve/ Locking cap guide Counter Torque, Long Tab Screw Vertebral body cavity creation instrument, medium Second Dilator Jig for 1 Level Plate Counter torque- Reduction Screw Ratcheting quick connect T handle Rod Inserter Threaded Shaft Rod Confirmer Rod Inserter Sleeve Alignment Instrument: Prongs Holder: Outer Hex Tube Counter Torque NT Blade 20mm (Spine Retractor) Tower Clip Reducer Counter Torque Threaded attachments- M8 Reducer attachment Ratcheting quick connect T handle Cannulated Long Reducer Lumbar Trocar Screw confirmation tool Threaded attachments- M6 Forth Dilator Alignment Instrument Prongs Assembly C-C Derotator Connection: Short First Dilator Rod Lever NT Blade 10mm (Spine Retractor) Threaded attachments- M4 Pedicle Finder Custom Paddle Distractor Flanged Connector Guide

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device