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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 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 2019-01-09 under 510(k) 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. The listed applicant is G21, S.R.L.. The 510(k) number is K181282.

When did G3A 40 Bone Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for G3A 40 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 G3A 40 Bone Cement?

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

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

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.

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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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