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FDA 510(k)

OrthoSteady G Bone Cement

K-Number: K173494 · 2018-03-06

ApplicantG21, S.R.L.
Decision Date2018-03-06
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoSteady G Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is G21, S.R.L.. It received FDA 510(k) clearance on 2018-03-06 under 510(k) 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. The listed applicant is G21, S.R.L.. The 510(k) number is K173494.

When did OrthoSteady G Bone Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for OrthoSteady G Bone Cement?

The FDA 510(k) record lists G21, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing G21, S.R.L. as applicant

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Related Devices (Code: LOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254107Refobacin Bone Cement R (110034355)Biomet FranceK250760SPECTRUM GV Bone CementOsteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV Bone CementOsteoremedies, LLCK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

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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