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HPZ — Implant, Eye Sphere Class II

FDA Device Classification

Classification Details

Product Code
HPZ
Device Class
Class II
Regulation Number
886.3320
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212741fci (france chirurgie instrumentation)EZYPORJune 24, 2022
K123764oculo-plastikDURETTE OCULAR IMPLANTJanuary 31, 2013
K110554ceramisysBIOCERAMIC ORBITAL IMPLANT, ORBTEXNovember 2, 2011
K112176oculo plastikSILICONE SPHERESSeptember 15, 2011
K083342evera medicalORBITAL RECONSTRUCTIVE IMPLANT IIMarch 12, 2009
K082850product and educational servicesEYE SPHERESFebruary 27, 2009
K073293oculo plastikDURETTE IMPLANTMarch 19, 2008
K071335porex surgicalMEDPOR ATTRACTOR IMPLANTAugust 8, 2007
K070130becker and associates consultingORBITAL RECONSTRUCTIVE IMPLANTApril 19, 2007
K053298hydron pty limitedALPHASPHERE ORBITAL IMPLANTMay 9, 2006
K040851porex surgicalMEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEMJuly 16, 2004
K040689oculo plastikEYE SPHERE IMPLANTSJune 10, 2004
K023400fci ophthalmicsFCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTAugust 22, 2003
K021643laboratoire villanovaHA ORBITAL IMPLANTDecember 13, 2002
K021357porex surgicalMEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANTAugust 5, 2002
K010902porex surgicalMEDPOR QUAD MOTILITY IMPLANTJune 19, 2001
K003338integrated orbital implantsBIO-EYE II ORBITAL IMPLANTFebruary 7, 2001
K992294fci ophthalmicsBIOCERAMIC ORBITAL IMPLANTApril 19, 2000
K982562integrated orbital implantsBIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMERDecember 28, 1998
K972143iopMOA BONE / M-SPHEREOctober 16, 1997