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Sign in to claim this brandG21 SRL
US
Last updated May 25, 2026
What G21 SRL makes
G21 SRL manufactures orthopaedic devices for spinal and bone procedures, including moulds for cement spacers, balloon kyphoplasty kits for vertebral augmentation, and kits for preparing and delivering orthopaedic cement. Their portfolio also includes antimicrobial and non-antimicrobial bone cement, cannulae for vertebral body cement injection, bone access channel kits, and reusable surgical procedure kits for orthopaedic use.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. G21 SRL operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does G21 SRL manufacture?
G21 SRL specializes in orthopaedic devices primarily used in spinal and bone procedures. Their product range includes orthopaedic cement spacer moulds, balloon kyphoplasty kits for vertebral augmentation, cement preparation and delivery kits, and both antimicrobial and non-antimicrobial orthopaedic cement. They also produce tools like vertebral body cement cannulae, bone access channel kits, and reusable orthopaedic surgical procedure kits. These devices support procedures such as spinal stabilization and bone cement application.
Where is G21 SRL based, and what regulatory jurisdiction does it operate under?
G21 SRL is based in the United States. As a manufacturer, it must comply with U.S. regulatory requirements for medical devices, including those set by the FDA. The company’s devices are designed and marketed within this jurisdiction, adhering to applicable standards for safety, performance, and compliance.
Which regulatory registries or databases list G21 SRL’s devices?
G21 SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices. The UDI system is a key tool for tracking Class I and Class II devices, which include G21 SRL’s orthopaedic and spinal products.
How are G21 SRL’s devices classified under FDA regulations?
G21 SRL’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. For example, orthopaedic cement spacer moulds and reusable surgical kits may qualify as Class I, whereas balloon kyphoplasty kits or antimicrobial bone cement could be classified as Class II, depending on their intended use and potential risks. Classification determines the regulatory pathway and oversight required for each device.
What is the purpose of devices like the balloon kyphoplasty kit or orthopaedic cement preparation kits manufactured by G21 SRL?
Devices like the balloon kyphoplasty kit are designed for vertebral augmentation, a procedure used to treat vertebral compression fractures by expanding a balloon within the affected vertebra to restore height and stability before filling it with bone cement. Orthopaedic cement preparation and delivery kits, such as mixing bowls or syringe guns, ensure precise handling and application of bone cement during surgical procedures. These tools collectively support spinal stabilization and fracture repair, improving patient outcomes by enhancing bone integrity and alignment.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 431529195
Catalogue (73)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EasyWinch 15 mm | 900198 | FDA UDI | Class II | Active |
| CeMend 8-42 mold insert press | AR-902-02 | FDA UDI | Class II | Active |
| V-Access | VV 15 150 5 | FDA UDI | Class I | Active |
| CeMend Shoulder Spacer Mold | AR-902-1242M | FDA UDI | Class II | Active |
| PicoMix Syringe | 900209 | FDA UDI | Class I | Active |
| CeMend 10-48 mold insert press | AR-902-04 | FDA UDI | Class II | Active |
| Bravo Mv | 610-01-040 | FDA UDI | Class II | Active |
| SpaceFlex Knee Trial | 900201 | FDA UDI | Class I | Active |
| Arthrex Bone Cement Mixing Syringe | AR-901-3 | FDA UDI | Class I | Active |
| SpaceFlex Acetabular Cup | 900203 | FDA UDI | Class II | Active |
| Winch Kyphoplasty Bilateral Kit 8G 15 mm | 900207B | FDA UDI | Class II | Active |
| Arthrex Bone Cement MV w/G | AR-901-MVG | FDA UDI | Class II | Active |
| Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter | 900027 | FDA UDI | Class II | Unknown |
| CeMend 10-42 mold insert press | AR-902-03 | FDA UDI | Class II | Active |
| Arthrex Bone Cement MV | AR-901-MV | FDA UDI | Class II | Active |
| Arthrex Bone Cement HV | AR-901-HV | FDA UDI | Class II | Active |
| Arthrex Bone Cement HV | AS-901-HV | FDA UDI | Class II | Active |
| Winch Kyphoplasty Kit 20 mm | 900018 | FDA UDI | Class II | Active |
| KeyFix Direct Access Needle | 900094 | FDA UDI | Class I | Active |
| Arthrex Bone Cement MV | AS-901-MV | FDA UDI | Class II | Active |
| CeMend Shoulder Spacer Mold | AS-902-1242M | FDA UDI | Class II | Active |
| CeMend Shoulder Spacer Mold | AR-902-1248M | FDA UDI | Class II | Active |
| WKK Traditional Access | 900019 | FDA UDI | Class I | Active |
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