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FDA 510(k)

G3A 40 Bone Cement

K-Number: K181282 · 2019-01-09

ApplicantG21, S.R.L.
Decision Date2019-01-09
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G3A 40 Bone Cement is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2019-01-09 under approval number K181282. 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 G3A 40 Bone Cement?

G3A 40 Bone Cement is a medical device that received FDA 510(k) clearance on 2019-01-09. It is manufactured by G21, S.R.L.. The 510(k) number is K181282.

When was G3A 40 Bone Cement approved by the FDA?

G3A 40 Bone Cement received FDA 510(k) clearance on 2019-01-09, under approval number K181282.

What company makes G3A 40 Bone Cement?

G3A 40 Bone Cement is manufactured by G21, S.R.L..

What is the FDA product code for G3A 40 Bone Cement?

The FDA product code for G3A 40 Bone Cement is LOD.

Other Devices by G21, S.R.L.

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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.

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