CustomizedBone Service
K-Number: K193547 · 2020-01-17
ApplicantFin-Ceramica Faenza S.P.A.
Decision Date2020-01-17
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 2020-01-17 under approval number K193547. 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 2020-01-17. It is manufactured by Fin-Ceramica Faenza S.P.A.. The 510(k) number is K193547.
When was CustomizedBone Service approved by the FDA?
CustomizedBone Service received FDA 510(k) clearance on 2020-01-17, under approval number K193547.
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.