Company ยท IT
G21, S.R.L.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2025 | K252443 | SpaceFix Shoulder Spacer G21, S.R.L., IT | MBB |
| Mar 23, 2023 | K223441 | SpaceFlex Acetabular Cup G21, S.R.L., IT | KWY |
| Feb 17, 2021 | K202338 | SpaceFlex Shoulder G21, S.R.L., IT | MBB |
| Aug 13, 2020 | K201960 | SpaceFlex Knee - 80mm Size G21, S.R.L., IT | MBB |
| Mar 19, 2020 | K193061 | G3 40 Radiopaque Bone Cement G21, S.R.L., IT | LOD |
| Mar 19, 2020 | K193059 | G1 40 Radiopaque Bone Cement G21, S.R.L., IT | LOD |
| Oct 29, 2019 | K192041 | G21 SpaceFlex Hip G21, S.R.L., IT | MBB |
| Jun 9, 2019 | K190216 | SpaceFlex Knee G21, S.R.L., IT | MBB |
| Jan 9, 2019 | K181282 | G3A 40 Bone Cement G21, S.R.L., IT | LOD |
| Mar 6, 2018 | K173494 | OrthoSteady G Bone Cement G21, S.R.L., IT | LOD |
| Feb 23, 2016 | K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters G21, S.R.L., IT | NDN |
| Dec 14, 2015 | K150408 | V-STEADY, V-FAST G21, S.R.L., IT | LOD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||