G21 S.R.I.

FDA Device Registration & Listing · San Possidonio Modena, IT · Registration 3010898856

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010898856
FEI Number
3010898856
Entity Name
G21 S.R.I.
City/State/Country
San Possidonio Modena, IT
Establishment Address
Via S. Pertini, 8, San Possidonio Modena 41039, IT
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
G21 s.r.l. (Owner Number: 10051231)
Owner / Operator Contact Address
Via S. Pertini, 8, San Possidonio, IT-MO 41039, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-10-09
HRX Arthroscope Orthopedic Class 2 888.1100 2017-10-09
HTW Bit, Drill Orthopedic Class 1 888.4540 2016-02-21
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2019-03-05
LOD Bone Cement Orthopedic Class 2 888.3027 2019-03-05
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-03-30
HTF Curette General, Plastic Surgery Class 1 878.4800 2017-09-08
HWT Template Orthopedic Class 1 888.4800 2021-01-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-02-28
LOD Bone Cement Orthopedic Class 2 888.3027 2016-02-28
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2019-06-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-06-11
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2019-10-30
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2019-10-30
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2019-10-30
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2018-04-23
LOD Bone Cement Orthopedic Class 2 888.3027 2018-04-23
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2016-02-21
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2025-11-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-11-19
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2016-08-11
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2016-02-28
HRX Arthroscope Orthopedic Class 2 888.1100 2016-02-28
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-02-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2023-04-07
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-04-07
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2025-02-13

Official Correspondent

Maurizio Foroni

US Agent Details

Barry Sands Business: Regulatory/Quality Management Information Source, Inc. Email: fdaadminsupport@rqmis.com Phone: (978) 8345701

Related Public Records

Same Entity

G21 s.r.l.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22
K030577 Stelkast Company PROVEN MODULAR TIBIAL TRAY 2003-03-25
K153310 Total Joint Orthopedics, Inc. Klassic Knee System 2015-12-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010898856. Last updated year: 2026. Please use registration number 3010898856 when referencing this establishment in official correspondence.
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