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FDA 510(k)

Refobacin Bone Cement R

K-Number: K171540 · 2017-08-30

ApplicantBiomet, Inc.
Decision Date2017-08-30
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Refobacin Bone Cement R is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2017-08-30 under approval number K171540. 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?

Refobacin Bone Cement R is a medical device that received FDA 510(k) clearance on 2017-08-30. It is manufactured by Biomet, Inc.. The 510(k) number is K171540.

When was Refobacin Bone Cement R approved by the FDA?

Refobacin Bone Cement R received FDA 510(k) clearance on 2017-08-30, under approval number K171540.

What company makes Refobacin Bone Cement R?

Refobacin Bone Cement R is manufactured by Biomet, Inc..

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.