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FDA 510(k)

Bone Cement Genta, Bone Cement HV, Bone Cement LV

K-Number: K211163 · 2023-01-09

ApplicantTecres S.P.A.
Decision Date2023-01-09
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bone Cement Genta, Bone Cement HV, Bone Cement LV is a medical device manufactured by Tecres S.P.A.. It received FDA 510(k) clearance on 2023-01-09 under approval number K211163. 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 Bone Cement Genta, Bone Cement HV, Bone Cement LV?

Bone Cement Genta, Bone Cement HV, Bone Cement LV is a medical device that received FDA 510(k) clearance on 2023-01-09. It is manufactured by Tecres S.P.A.. The 510(k) number is K211163.

When was Bone Cement Genta, Bone Cement HV, Bone Cement LV approved by the FDA?

Bone Cement Genta, Bone Cement HV, Bone Cement LV received FDA 510(k) clearance on 2023-01-09, under approval number K211163.

What company makes Bone Cement Genta, Bone Cement HV, Bone Cement LV?

Bone Cement Genta, Bone Cement HV, Bone Cement LV is manufactured by Tecres S.P.A..

What is the FDA product code for Bone Cement Genta, Bone Cement HV, Bone Cement LV?

The FDA product code for Bone Cement Genta, Bone Cement HV, Bone Cement LV is LOD.

Other Devices by Tecres S.P.A.

Related Devices (Code: LOD)

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.