(47 days)
The Spectrum Designs Medial Malar Implant is intended to augment or reconstruct the malar region of the face.
Spectrum Designs Medial Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
This document is a 510(k) summary for the Spectrum Designs Medial Malar Implant. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through a dedicated study. This document outlines the device description, indications for use, contraindications, and warnings related to the implant. It also identifies substantially equivalent devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.