FDA 510(k)

G1 40 Radiopaque Bone Cement

K-Number: K193059 · 2020-03-19

Decision Date2020-03-19

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

G1 40 Radiopaque Bone Cement is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2020-03-19 under approval number K193059. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G1 40 Radiopaque Bone Cement?

G1 40 Radiopaque Bone Cement is a medical device that received FDA 510(k) clearance on 2020-03-19. It is manufactured by G21, S.R.L.. The 510(k) number is K193059.

When was G1 40 Radiopaque Bone Cement approved by the FDA?

G1 40 Radiopaque Bone Cement received FDA 510(k) clearance on 2020-03-19, under approval number K193059.

What company makes G1 40 Radiopaque Bone Cement?

G1 40 Radiopaque Bone Cement is manufactured by G21, S.R.L..

What is the FDA product code for G1 40 Radiopaque Bone Cement?

The FDA product code for G1 40 Radiopaque Bone Cement is LOD.

Other Devices by G21, S.R.L.

K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters K173494OrthoSteady G Bone Cement K192041G21 SpaceFlex Hip K190216SpaceFlex Knee K181282G3A 40 Bone Cement K201960SpaceFlex Knee - 80mm Size

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Related Devices (Code: LOD)

K153737OSTEOPAL plusHeraeus Medical GmbH K172408Biomet Bone Cement RBiomet, Inc. K170802TRAUMACEM V+ Injectable Bone CementSynthes (USA) Products, LLC K171540Refobacin Bone Cement RBiomet, Inc. K182260PALACOS MVHeraeus Medical GmbH K173494OrthoSteady G Bone CementG21, S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.