Medical Device Manufacturer · IT , San Possidonio

G21, S.R.L.

12 submissions · 12 cleared · Since 2015
12
Total
12
Cleared
0
Denied

G21, S.R.L. — FDA 510(k) Submissions

G21, S.R.L. has submitted 12 FDA 510(k) premarket notifications since 2015, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bone Cement, Bone Cement, Antibiotic, Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented, Cement, Bone, Vertebroplasty . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
SpaceFix Shoulder Spacer
K252443 · MBB Bone Cement, Antibiotic · Orthopedic
Sep 2025 42d
SpaceFlex Acetabular Cup
K223441 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Mar 2023 129d
SpaceFlex Shoulder
K202338 · MBB Bone Cement, Antibiotic · Orthopedic
Feb 2021 184d
SpaceFlex Knee - 80mm Size
K201960 · MBB Bone Cement, Antibiotic · Orthopedic
Aug 2020 30d
G1 40 Radiopaque Bone Cement
K193059 · LOD Bone Cement · Orthopedic
Mar 2020 139d
G3 40 Radiopaque Bone Cement
K193061 · LOD Bone Cement · Orthopedic
Mar 2020 139d
G21 SpaceFlex Hip
K192041 · MBB Bone Cement, Antibiotic · Orthopedic
Oct 2019 90d
SpaceFlex Knee
K190216 · MBB Bone Cement, Antibiotic · Orthopedic
Jun 2019 125d
G3A 40 Bone Cement
K181282 · LOD Bone Cement · Orthopedic
Jan 2019 239d
OrthoSteady G Bone Cement
K173494 · LOD Bone Cement · Orthopedic
Mar 2018 113d
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
K152557 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Feb 2016 168d
V-STEADY, V-FAST
K150408 · LOD Bone Cement · Orthopedic
Dec 2015 299d
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