BEUDAMED
    FDA Registration Active 🇮🇳 India

    PERSUADER, GUN-STYLE- INNER TUBE

    Reg #: 3016443334 · FEI: 3016443334 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    95
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
    Registration Number
    3016443334
    FEI Number
    3016443334
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SURVEY NO-1540, BESIDE TORRENT PHARMA,, AHMEDABD-MEHSANA HIGHWAY, VILLAGE-RAJPUR
    City
    KADI Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K162160

    Owner / Operator

    Firm Name
    SOLCO BIOMEDICAL CO
    Operator Number
    10077960
    Address
    5 & 6, 3rd Floor, B. Jadav Chambers,, Ashram Road
    City
    AHMEDABAD
    State
    Gujarat
    Postal Code
    380009
    Country
    IN

    US Agent

    Business Name
    Carrasco
    Contact Name
    Mateo Carrasco
    Address
    1815 Barker drive
    City
    Winter Park
    State
    FL
    ZIP
    32789
    Country
    US
    Email
    [email protected]
    Phone
    407 2849480

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    PERSUADER, GUN-STYLE- INNER TUBE HEXALOBE DRIVER, SELF-RETAINING, CANNULATED, T25, SHORT Knob Adapter PERSUADER, GUN-STYLE APPLIANCE, FIXATION , SPINAL INTERLAMINAL Final Tightening Driver,T30, 7mm HEX Screwdriver, Adjustment/Removal, T25 K-Wire Driver Inserter, Set-Screw, Double-Sided Final Tightening Driver T30 7mm HEX Screw, Dual Lead, 7.5mm x 35-55 mm Head Inserter Rod Bender, In-Situ, Right Tap Double Lead 7.5mm(Cat No - C50-2000-075) Screw, Pedicle DL Cannulated, 8.5x50mm Headbody, Assembly, Reduction Screw, Dual Lead, 8.5mm x 35-110 mm Tap Double Lead 8.5mm Screw, Pedicle DL Cannulated, 6.5x55mm Driver Polyaxial Long Driver, Headless, 10 in Inserter, Set Screw, Expandable SCREW TO SCREW DISTRACTOR Spring Cage Persuader, Tower Tap Double Lead 4.5mm(Cat No - C50-2000-045) Driver Polyaxial Reduction Long(Cat No - C50-3000-009) Probe, Sounder, Straight Probe, Sounder, Curved Screw, Pedicle DL Cannulated, 7.5x50mm Cross Connector, 45mm(Cat No - C10-2900-045) Probe Sounder Straight(Cat No - C50-2000-002) Rod Bender In-Situ Right Cross Connector, 70mm(Cat No - C10-2900-070) Screw, Dual Lead, 6.5mm x 35-50 mm Screw, Dual Lead, 9.5mm x 35-100 mm Tap, Double Lead, 8.5mm Inserter, Set-Screw, Double-Sided(Cat No - C50-7000-001) Driver, Polyaxial, Long Probe Sounder Curved Screw, Dual Lead, 5.5mm x 30- 55 mm Tap Double Lead 8.5mm(Cat No - C50-2000-085) Persuader Tower Adapter(Cat No - C50-6000-005) Probe Sounder Straight SCREW, PEDICLE, DOUBLE LEAD, FLUTELESS DIA 7.5mm x 40-50 mm LONG Tap, Double Lead, 4.5mm Rod Bender In-Situ Left Headbody, Assembly, Reduction(Cat No - C51-1000-002) Tap Double Lead 6.5mm(Cat No - C50-2000-065) Tap Double Lead 6.5mm Screw, Pedicle DL Cannulated 5.5x30mm Cross Connector, 55mm Screw, Pedicle DL Cannulated, 7.5x40mm Cross Connector, 70mm SCREW, PEDICLE, DOUBLE LEAD, FLUTELESS DIA 6.5mm x 30-60 mm LONG Tap, Double Lead, 6.5mm Rod Forceps, Long, 5.5mm Cross Connector, 90mm Screw, Pedicle DL Cannulated, 5.5x55mm Driver Headless 10in Driver Adjustment / Removal T25 SCREW, PEDICLE, DOUBLE LEAD, FLUTELESS DIA 5.5mm x 40-55 mm LONG Cross Connector, 55mm(Cat No - C10-2900-055) Inserter Set Palm T30(Cat No - C50-7000-002) Screw, Pedicle DL Cannulated, 6.5x45mm Tap Double Lead 5.5mm Cross Connector, 45mm Rod Bender, In-Situ, Left HANDLE COLOR(Cat No - C50-7000-002) Head Reamer K-Wire_Driver Rod Gripper Slimline 5.5mm(Cat No - C27-4000-091) Screw, Pedicle DL Cannulated, 7.5x55mm Tap Double Lead 4.5mm Rod Forceps Long 5.5mm SET SCREW M6 X 0.5 L5 Tap, Double Lead, 5.5mm Driver Polyaxial Reduction Long Persuader, Tower, Adapter Screw, Dual Lead, 6.5mm x 60mm Screw, Pedicle DL 7.5x60mm Inserter Set Palm T30 HANDLE Rod Gripper Slimline 5.5mm Set screw, T30 Persuader Tower Adapter Tap Double Lead 7.5mm Saddle SET SCREW M6 X 1 L5 Tap, Double Lead, 7.5mm Set screw, T30(Cat No - C51-0000-000) Tap Double Lead 5.5mm(Cat No - C50-2000-055) Cross Connector, 90mm(Cat No - C10-2900-090) TRIAL SCREW Probe Sounder Curved(Cat No - C50-2000-001) Screw Distractor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)