(247 days)
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.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding "Ceramisys Synthetic Orbital Implants." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.
The letter is an administrative notice approving the device for marketing and mentions the indications for use, but it does not include data from performance studies. 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.