G21, S.R.L. is one of 126 FDA 510(k) medical device manufacturers from Italy in the dataset, ranked by real submission volume.
G21, S.R.L. - FDA 510(k) Cleared Devices
Recent clearances: SpaceFix Shoulder Spacer, SpaceFlex Acetabular Cup, SpaceFlex Shoulder
12
Total
12
Cleared
0
Denied
G21, S.R.L. has 12 FDA 510(k) cleared orthopedic devices. Based in San Possidonio, IT.
Latest FDA clearance: Sep 2025. Active since 2015.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by RQMIS, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - G21, S.R.L.
12 devices
Cleared
Sep 15, 2025
SpaceFix Shoulder Spacer
Orthopedic
42d
Cleared
Mar 23, 2023
SpaceFlex Acetabular Cup
Orthopedic
129d
Cleared
Feb 17, 2021
SpaceFlex Shoulder
Orthopedic
184d
Cleared
Aug 13, 2020
SpaceFlex Knee - 80mm Size
Orthopedic
30d
Cleared
Mar 19, 2020
G1 40 Radiopaque Bone Cement
Orthopedic
139d
Cleared
Mar 19, 2020
G3 40 Radiopaque Bone Cement
Orthopedic
139d
Cleared
Oct 29, 2019
G21 SpaceFlex Hip
Orthopedic
90d
Cleared
Jun 09, 2019
SpaceFlex Knee
Orthopedic
125d
Cleared
Jan 09, 2019
G3A 40 Bone Cement
Orthopedic
239d
Cleared
Mar 06, 2018
OrthoSteady G Bone Cement
Orthopedic
113d
Cleared
Feb 23, 2016
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
Orthopedic
168d
Cleared
Dec 14, 2015
V-STEADY, V-FAST
Orthopedic
299d