BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    G21 S.R.I.

    Reg #: 3010898856 · FEI: 3010898856 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    96
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    G21 S.R.I.
    Registration Number
    3010898856
    FEI Number
    3010898856
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via S. Pertini, 8
    City
    San Possidonio Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K172214

    Owner / Operator

    Firm Name
    G21 s.r.l.
    Operator Number
    10051231
    Address
    Via S. Pertini, 8
    City
    San Possidonio
    State
    Modena
    Postal Code
    41039
    Country
    IT
    Correspondent
    Maurizio Foroni

    US Agent

    Business Name
    Regulatory/Quality Management Information Source, Inc.
    Contact Name
    Barry Sands
    Address
    110 Haverhill Rd Ste 524
    City
    Amesbury
    State
    MA
    ZIP
    01913
    Country
    US
    Email
    [email protected]
    Phone
    978 8345701

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX
    Bit, Drill HTW
    Bone Cement, Antibiotic MBB
    Bone Cement LOD
    Orthopedic Manual Surgical Instrument LXH
    Curette HTF
    Template HWT
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Mixer, Cement, For Clinical Use JDZ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Instrument, Manual, Surgical, General Use MDM
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Pliers, Surgical HTC
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Dispenser, Cement KIH
    Rasp HTR

    Proprietary Names

    Winch Kyphoplasty 11 Gauge Balloon Catheters EasyWinch 20 mm WINCH KYPHOPLASTY KIT 8G, 15MM WINCH BILATERAL KYPHOPLASTY KIT,15MM WINCH BILATERAL KYPHOPLASTY KIT,20MM WINCH KYPHOPLASTY KIT, 15MM EasyWinch 15 mm WINCH KYPHOPLASTY KIT 8G, 20MM WINCH KYPHOPLASTY KIT, 20MM WINCH BILATERAL KYPHOPLASTY KIT 8G, 15MM WINCH BILATERAL KYPHOPLASTY KIT 8G, 20MM KeyFix Bone Drill G3A 40 Bone Cement BRAVO MV+G Arthrex Bone Cement MV w/G WKK First Acces Needle WKK Guide Wire, Trocar and Round Tip WKK Cannulated Working Cannula WKK TRADITIONAL ACCESS Curette - Flex Drill SpaceFlex Hip trial SpaceFlex Knee trial Cemend Shoulder Spacer Trial 1042 Cemend Shoulder Spacer Trial 1048 Reamer T-handle CeMend Shoulder Spacer Trial 12-48 CeMend Reamer 12mm CeMend Reamer 14mm CeMend Shoulder Spacer Reamer Tray Cemend Shoulder Spacer Trial 08 42 CeMend Reamer 8mm CeMend Reamer 10mm V-FAST Bone Cement V-STEADY Bone Cement SpaceFlex Knee SpaceFlex Hip SpaceFlex Hip Instrument kit OrthoSteady G ASC Cementation Kit 2 ASC Cementation Kit 4 Arthrex Bone Cement HV w/G BRAVO HV+G PICOMIX V, MIXING SYSTEM AND DELIVERY SYRINGES DISP MIXING BOWL-O: OPEN MIXING SYSTEM FOR BONE CEMENT PREPARATION PICOMIX BOWL:BONE CEMENT CLOSED MIXING SYSTEM PICOMIX SYRINGE BONE CEMENT MIXING SYSTEM (180GR) PICOMIX SYRINGE BONE CEMENT MIXING SYSTEM (120GR) Arthrex Bone Cement Mixing Syringe Arthrex Bone Cement Open Mixing Bowl Arthrex Bone Cement Closed Mixing Bowl CeMend Shoulder Spacer 12 48 CeMend Shoulder Spacer 10 42 SpaceFix Shoulder Spacer 12 48 SpaceFix Shoulder Spacer 10 42 SpaceFix Shoulder Spacer 10 48 CeMend Shoulder Spacer 08 42 CeMend Shoulder Spacer 10 48 SpaceFix Shoulder Spacer 08 42 V-HP Gun, High pressure gun for bone cement injection WKK INJECTION KIT KeyFix Filler Cannula for Fenestrated Screw 8-16 G Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheter SpaceFlex Acetabular Cup CeMend Cemet Mold Pilers G1 40 ASC Cementation Kit 1 ASC Cementation Kit 3 Arthrex Bone Cement HV BRAVO HV KeyFix Direct Access Needle Blue Diamond Digital Inflation Device Atrion QL2530 Inflation Device VacLok Vacuum Pressure Syringe KeyFix Bone Cement Filler Cannula V-Access SpaceFlex Shoulder CeMend 10-42 mold insert press CeMend Base Compression Bolt CeMend 8-42 mold insert press CeMend 48mm head insert CeMend 14-48 mold insert press SpaceFlex Shoulder Instrument kit CeMend Core Extension CeMend 42mm head insert CeMend Mold Base CeMend Shoulder Spacer Mold CeMend 10-48 mold insert press CeMend 12-42 mold insert press CeMend 12-48 mold insert press SpaceFlex Shoulder Core Extension CeMend Shoulder Mold Tray Flex Filler CeMend Cemet Mold Rasp G3 40 BRAVO MV Arthrex Bone Cement MV

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device