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G21, S.R.L.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories4
Latest FDA decision2025-09-15
TypeNumberDevice NameCodeDateActions
510(k) K252443 SpaceFix Shoulder SpacerMBB2025-09-15 View
510(k) K223441 SpaceFlex Acetabular CupKWY2023-03-23 View
510(k) K202338 SpaceFlex ShoulderMBB2021-02-17 View
510(k) K201960 SpaceFlex Knee - 80mm SizeMBB2020-08-13 View
510(k) K193059 G1 40 Radiopaque Bone CementLOD2020-03-19 View
510(k) K193061 G3 40 Radiopaque Bone CementLOD2020-03-19 View
510(k) K192041 G21 SpaceFlex HipMBB2019-10-29 View
510(k) K190216 SpaceFlex KneeMBB2019-06-09 View
510(k) K181282 G3A 40 Bone CementLOD2019-01-09 View
510(k) K173494 OrthoSteady G Bone CementLOD2018-03-06 View
510(k) K152557 Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersNDN2016-02-23 View
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