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510(k) Data Aggregation
K Number
K110554Device Name
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
Manufacturer
CERAMISYS LTD.
Date Cleared
2011-11-02
(247 days)
Product Code
HPZ
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
CERAMISYS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.
Device Description
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