Medical Device Manufacturer · IT , San Possidonio

G21, S.R.L. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2015

12

Total

12

Cleared

0

Denied

FDA 510(k) cleared devices by G21, S.R.L. Orthopedic ✕

12 devices

1-12 of 12

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

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