CustomizedBone Service

Plate, Cranioplasty, Preformed, Non-alterable

Fin-Ceramica Faenza Spa

The following data is part of a premarket notification filed by Fin-ceramica Faenza Spa with the FDA for Customizedbone Service.

Pre-market Notification Details

Device IDK193547
510k NumberK193547
Device Name:CustomizedBone Service
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant Fin-Ceramica Faenza Spa Via Ravegnana 186 Faenza,  IT 48018
ContactMarina Monticelli
CorrespondentMary Beth Henderson
Regulatory And Clinical Research Institute, Inc. 5353 Wayzata Blvd, Suite 505 Minneapolis,  MN  55416
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-01-17

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