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FDA 510(k)

Refobacin Bone Cement R (110034355)

K-Number: K254107 · 2026-04-15

ApplicantBiomet France
Decision Date2026-04-15
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Refobacin Bone Cement R (110034355) is a medical device manufactured by Biomet France. It received FDA 510(k) clearance on 2026-04-15 under approval number K254107. 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 Refobacin Bone Cement R (110034355)?

Refobacin Bone Cement R (110034355) is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by Biomet France. The 510(k) number is K254107.

When was Refobacin Bone Cement R (110034355) approved by the FDA?

Refobacin Bone Cement R (110034355) received FDA 510(k) clearance on 2026-04-15, under approval number K254107.

What company makes Refobacin Bone Cement R (110034355)?

Refobacin Bone Cement R (110034355) is manufactured by Biomet France.

What is the FDA product code for Refobacin Bone Cement R (110034355)?

The FDA product code for Refobacin Bone Cement R (110034355) is LOD.

Related Devices (Code: 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.

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