FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.
FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number: K180513
Device Name: CustomizedBone Service
Applicant: Fin-Ceramica Faenza S.P.A.
Regulation Number: 882.533
Classification Product Code: GXN
Date Received: 02/27/2018
Decision Date: 05/15/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Neurology
Total number of pages: 669
Fully redacted pages: 384
Content pages: 285
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