G21, S.R.L.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “G21, S.R.L.” (first 2015, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 127 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 299 |
| 2016 | 1 | 168 |
| 2017 | 0 | — |
| 2018 | 1 | 113 |
| 2019 | 3 | 125 |
| 2020 | 3 | 139 |
| 2021 | 1 | 184 |
| 2022 | 0 | — |
| 2023 | 1 | 129 |
| 2024 | 0 | — |
| 2025 | 1 | 42 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name G21, S.R.L. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOD | Bone Cement | 5 | 5 |
| MBB | Bone Cement, Antibiotic | 5 | 5 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| NDN | Cement, Bone, Vertebroplasty | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent G21, S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | MBB | 2025-09-15 | 42 |
| K223441 | SpaceFlex Acetabular Cup | KWY | 2023-03-23 | 129 |
| K202338 | SpaceFlex Shoulder | MBB | 2021-02-17 | 184 |
| K201960 | SpaceFlex Knee - 80mm Size | MBB | 2020-08-13 | 30 |
| K193061 | G3 40 Radiopaque Bone Cement | LOD | 2020-03-19 | 139 |
| K193059 | G1 40 Radiopaque Bone Cement | LOD | 2020-03-19 | 139 |
| K192041 | G21 SpaceFlex Hip | MBB | 2019-10-29 | 90 |
| K190216 | SpaceFlex Knee | MBB | 2019-06-09 | 125 |
| K181282 | G3A 40 Bone Cement | LOD | 2019-01-09 | 239 |
| K173494 | OrthoSteady G Bone Cement | LOD | 2018-03-06 | 113 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named G21, S.R.L..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under G21, S.R.L.?
FDA lists 12 510(k) clearances under the applicant name “G21, S.R.L.” (first 2015, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by G21, S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name G21, S.R.L. is 134 days. Since 2017: 127 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under G21, S.R.L.?
The most frequent FDA product codes under this applicant name are LOD (Bone Cement, 5); MBB (Bone Cement, Antibiotic, 5); KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, 1).
Next steps
- See all 12 G21, S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code LOD, G21, S.R.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.