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510(k) Data Aggregation
K Number
K240567Device Name
CustomizedBone Service
Manufacturer
Date Cleared
2024-03-28
(28 days)
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
Fin-ceramica faenza s.p.a
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- removal of tumours;
- reabsorption of autologous bone;
- rejection of other prosthetic materials;
- congenital malformations.
Device Description
CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:
- macro-pores,
- interconnecting pores,
- micro-pores.
This material is biocompatible.
The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.
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K Number
K180513Device Name
CustomizedBone Service
Manufacturer
Date Cleared
2018-05-15
(77 days)
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
Fin-Ceramica Faenza S.p.A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge) . This device is indicated for both adult and pediatric use (for children 7 years of age and above).
CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- · removal of tumours:
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Device Description
Not Found
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