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FDA approval
20.01.17    Finish line

FDA approval

Finceramica has obtained the US product marketing authorization issued by the Food and Drug Administration (FDA).

CustomizedBone Service, which is how the well-known CustomBone Service is trademarked in the US, obtained this approval following the submission of a "510k" file, aimed at proving substantial equivalence of the Italian device to at least another (predicate) device already legally marketed in the US, hence, already FDA approved. The dossier must be complete with, among other things, product details, comparative tests, and clinical data. The time required for approval generally depends on the complexity of the case and on how equivalent the compared devices actually are. CustomizedBone was a particular case, as this is the only FDA approved porous hydroxyapatite device for this type of therapeutic indication.

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SECURITY NOTICE Cross-border falsification of devices
15.03.22  Urgent alert

SECURITY NOTICE Cross-border falsification of devices

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Strategic Licensing Agreement with Kelnyam Global, Inc.
23.12.21  Goals

Strategic Licensing Agreement with Kelnyam Global, Inc.

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Merry Christmas and Happy 2022
17.12.21  Charity

Merry Christmas and Happy 2022

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100 ITALIAN LIFE SCIENCES STORIES
10.05.21  Awardness

100 ITALIAN LIFE SCIENCES STORIES

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Close to schools
30.03.21  School

Close to schools

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Available online, in any web store, the first Finceramica's APP
20.02.18  Finish line

Available online, in any web store, the first Finceramica's APP

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The 2017 AboutPharma Digital Award goes to Finceramica
27.10.17  Awards

The 2017 AboutPharma Digital Award goes to Finceramica

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ICRS Heritage Summit
08.06.17  Events

ICRS Heritage Summit

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