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510(k) Data Aggregation
(107 days)
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the occular implant to the prosthetic eye.
Titanium nitride coated stainless steel screw, ATTRACTOR SCREW, is designed to be placed into the MEDPOR implant, so that the head of the screw is placed at the anterior appx of the implant as it site in the orbit. The flat head of the screw is flush with the surface of the implant and is covered with the verlying tissue. Magnets of appropriate material, shape, and size to be imbedded into the posterior of the prosthetic eye. The magnets are designed small enough to remain enlinely within the posterior of the prostinents and and any and a belgives onlike the sgrowing force between the imaterial (typically accylic) of the prosthelic eye, and powerful enough to provide a coupling force between th
The provided text describes a 510(k) premarket notification for the MEDPOR Attractor Magnetic Coupling System. It includes information about the device, its indications for use, and a study conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
Acceptance Criteria (Implied) | Reported Device Performance |
---|---|
Improved prosthesis motility | Significant improvement in lateral excursion motility (P |
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