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510(k) Data Aggregation
K Number
K021643Device Name
HA ORBITAL IMPLANT
Manufacturer
Date Cleared
2002-12-13
(207 days)
Product Code
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
LABORATOIRE VILLANOVA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca10(PO4)6 (OH)2) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
Device Description
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca1o(P04)s (OH)2) implants with a minimal 95 % quaranteed purity. Their porosity is 75% (pore diameter: 200-500 um). The porosity of the hydroxyapatite facilitates its colonization by fibrovascular tissue, which offers the advantages of reduced risk of infection or implant extrusion. They are available in the following diameters: 16, 17, 18, 19, 20 and 22 mm.
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