G21, S.R.L.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
3
Compliance Actions
0

Known Names

g21, g-21

Recent 510(k) Clearances

K-NumberDeviceDate
K252443SpaceFix Shoulder SpacerSeptember 15, 2025
K223441SpaceFlex Acetabular CupMarch 23, 2023
K202338SpaceFlex ShoulderFebruary 17, 2021
K201960SpaceFlex Knee - 80mm SizeAugust 13, 2020
K193059G1 40 Radiopaque Bone CementMarch 19, 2020
K193061G3 40 Radiopaque Bone CementMarch 19, 2020
K192041G21 SpaceFlex HipOctober 29, 2019
K190216SpaceFlex KneeJune 9, 2019
K181282G3A 40 Bone CementJanuary 9, 2019
K173494OrthoSteady G Bone CementMarch 6, 2018
K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersFebruary 23, 2016
K150408V-STEADY, V-FASTDecember 14, 2015