(132 days)
Hydroxyapitate orbital implants are indicated for post enucleation patients. This product is intended to establish a platform to affix an artificial eye that becomes integrated with the patients tissues.
Moa Bone™ - Hydroxyapitate Orbital Implant
This document is a 510(k) premarket notification letter from the FDA for a medical device called "Moa Bone™ - Hydroxyapatite Orbital Implant." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily addresses the substantial equivalence determination for marketing the device.
Therefore, I cannot provide the requested information based on the provided text.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.