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FDA 510(k)

Biomet Bone Cement R

K-Number: K172408 · 2017-10-05

ApplicantBiomet, Inc.
Decision Date2017-10-05
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Bone Cement R is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K172408. 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 Biomet Bone Cement R?

Biomet Bone Cement R is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Biomet, Inc.. The 510(k) number is K172408.

When did Biomet Bone Cement R receive FDA 510(k) clearance?

Biomet Bone Cement R received FDA 510(k) clearance on 2017-10-05, under 510(k) number K172408.

Who is the listed applicant for Biomet Bone Cement R?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biomet Bone Cement R?

The FDA product code for Biomet Bone Cement R is LOD.

Related Clinical Trials

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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Other records listing Biomet, Inc. 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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