Data / Medical devices / Italy / G21 S.R.I.
G21 S.R.I.: FDA-registered device maker in San Possidonio Modena, Italy, 13 510(k) clearances
G21 S.R.I. is registered with the FDA (registration 3010898856) in San Possidonio Modena, Italy. It lists 20 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010898856
- Address
- Via S. Pertini, 8, San Possidonio Modena, Italy, 41039
- Owner or operator
- G21 s.r.l. (10051231)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 21, 2016
- Registered through
- 2027
- Brand names listed
- ASC Cementation Kit 1, ASC Cementation Kit 2, ASC Cementation Kit 3, ASC Cementation Kit 4, Arthrex Bone Cement Closed Mixing Bowl, Arthrex Bone Cement HV, Arthrex Bone Cement HV w/G, Arthrex Bone Cement MV and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2025 | K252443 | SpaceFix Shoulder Spacer | MBB | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| March 23, 2023 | K223441 | SpaceFlex Acetabular Cup | KWY | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| February 17, 2021 | K202338 | SpaceFlex Shoulder | MBB | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| August 13, 2020 | K201960 | SpaceFlex Knee - 80mm Size | MBB | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| March 19, 2020 | K193061 | G3 40 Radiopaque Bone Cement | LOD | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| March 19, 2020 | K193059 | G1 40 Radiopaque Bone Cement | LOD | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| October 29, 2019 | K192041 | G21 SpaceFlex Hip | MBB | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| June 9, 2019 | K190216 | SpaceFlex Knee | MBB | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| January 9, 2019 | K181282 | G3A 40 Bone Cement | LOD | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| March 6, 2018 | K173494 | OrthoSteady G Bone Cement | LOD | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| August 23, 2017 | K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | NDN | Substantially Equivalent | G-21 S.R.L. | accessdata.fda.gov |
| February 23, 2016 | K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | NDN | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
| December 14, 2015 | K150408 | V-STEADY, V-FAST | LOD | Substantially Equivalent | G21, S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Bone Cement, Antibiotic
- All makers of Spinal Channeling Instrument, Vertebroplasty
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Rasp
Updated September 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.