CustomizedBone Service
K-Number: K180513 · 2018-05-15
ApplicantFin-Ceramica Faenza S.P.A.
Decision Date2018-05-15
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
CustomizedBone Service is a medical device manufactured by Fin-Ceramica Faenza S.P.A.. It received FDA 510(k) clearance on 2018-05-15 under approval number K180513. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CustomizedBone Service?
CustomizedBone Service is a medical device that received FDA 510(k) clearance on 2018-05-15. It is manufactured by Fin-Ceramica Faenza S.P.A.. The 510(k) number is K180513.
When was CustomizedBone Service approved by the FDA?
CustomizedBone Service received FDA 510(k) clearance on 2018-05-15, under approval number K180513.
What company makes CustomizedBone Service?
CustomizedBone Service is manufactured by Fin-Ceramica Faenza S.P.A..
What is the FDA product code for CustomizedBone Service?
The FDA product code for CustomizedBone Service is GXN.
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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.