G-21 S.R.L.
Italy IT-MF-000030085 Last updated 22 Oct 2026 Part of G21 S.R.L.
- Devices
- 58
- Registries
- EUDAMEDGUDIDFDA 510(k)
- FDA recalls
- 0
Catalogue
Vertebroplasty Kit Ref VK01 11 150 5
Vertebroplasty Kit Ref VK01 13 120 5
Vertebroplasty Kit Ref VK01 11 120 5
Vertebroplasty Kit Ref VK01 13 150 5
KeyFix Bone Cement Filler Cannula Ref 900097
Winch Kyphoplasty Balloon Catheter 11G 20mm Ref 900028
SpaceFlex Knee Ref 900189 60
Disp. Mixing Bowl-O Ref 900050
V-Fast Dh Ref 800016
PicoMix Syringe 180g Ref G210.00.010
G1A 40 Ref 800007
SpaceFlex Shoulder Ref G210.00.014
G1 20 Ref G210.00.001
PicoMix Syringe 180g Ref 900123-1
G3A 20 Ref G210.00.047
KeyFix Bone Drill Ref 900141
Flex Drill Ref 900212
V-Access Ref VV 13 120 5
G3 40 Ref 800004
SpaceFlex Shoulder Ref 900001 12 42 15
V-HP Gun Ref 900165
SpaceFlex Shoulder Ref G210.00.013
G1 40 Ref G210.00.002
SpaceFlex Shoulder Ref 900001 12 48 18
PicoMix Bowl Ref 900122
SpaceFlex Hip Ref 900005 10
G3 20 Ref G210.00.003
G1A 20 Ref G210.00.045
G1A 20 Ref 800006
KeyFix Direct Access Needle Ref 900103
V-Steady Ref 800039
PicoMix Syringe 120g Ref 900123
SpaceFlex Knee Ref 900189 70
V-Access Ref VV 11 120 5
PicoMix Syringe 120g Ref G210.00.009
V-Access Ref VV 13 150 5
be.ever Ref 80TBD039
SpaceFlex Hip Ref G210.00.019
SpaceFlex Shoulder Ref 900001 10 48 18
V-Fast Ref 800036
G1A 40 Ref G210.00.046
SpaceFlex Shoulder Ref 900001 14 48 18
SpaceFlex Shoulder Ref 900001 10 42 15
Biopsy Kit Ref VV 10 190 8
SpaceFlex Shoulder Ref G210.00.016
V-Access Ref VV 11 150 5
KeyFix Bone Cement Filler Cannula Ref 900100
SpaceFlex Shoulder Ref 900001 08 42 15
Showing 1-50 of 58
What G-21 S.R.L. makes
G-21 S.R.L. manufactures modified 11-gauge balloon catheters designed for kyphoplasty procedures, available in 15 mm and 20 mm lengths for spinal stabilization.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does G-21 S.R.L. manufacture?
G-21 S.R.L. specializes in modified 11-gauge balloon catheters specifically designed for kyphoplasty procedures. These devices come in two sizes: 15 mm and 20 mm lengths, and are intended for spinal stabilization during surgical interventions.
Where is G-21 S.R.L. based?
G-21 S.R.L. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the region.
How are the devices manufactured by G-21 S.R.L. classified under FDA regulations?
The devices produced by G-21 S.R.L., such as the modified kyphoplasty balloon catheters, fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notification (510(k)) submissions.
Which regulatory registries or pathways list the devices made by G-21 S.R.L.?
The devices manufactured by G-21 S.R.L., including their modified kyphoplasty balloon catheters, are listed via the FDA’s 510(k) pathway. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, allowing it to enter the market under FDA oversight.
Information
- Country
- Italy
- Address
- 8, via Sandro Pertini, San Possidonio, Italy
- Website
- www.g-21.it
- [email protected]
- Phone
- + 39 0535 30312
- EUDAMED SRN
- IT-MF-000030085