FDA 510(k)

OrthoSteady G Bone Cement

K-Number: K173494 · 2018-03-06

Decision Date2018-03-06

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OrthoSteady G Bone Cement is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2018-03-06 under approval number K173494. 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 OrthoSteady G Bone Cement?

OrthoSteady G Bone Cement is a medical device that received FDA 510(k) clearance on 2018-03-06. It is manufactured by G21, S.R.L.. The 510(k) number is K173494.

When was OrthoSteady G Bone Cement approved by the FDA?

OrthoSteady G Bone Cement received FDA 510(k) clearance on 2018-03-06, under approval number K173494.

What company makes OrthoSteady G Bone Cement?

OrthoSteady G Bone Cement is manufactured by G21, S.R.L..

What is the FDA product code for OrthoSteady G Bone Cement?

The FDA product code for OrthoSteady G Bone Cement is LOD.

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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.