SIS FACIAL CYLINDER, SIS FACIAL IMPLANT

• K Number: K070738
• Device Name: SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
• Manufacturer: COOK BIOTECH, INC.
• Date Cleared: 2007-04-05 ( 20 days)
• Product Code: FTM
• Regulation Number: 878.3300
• Type: Special
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "SIS Facial Implant." It is not a study report or clinical trial documentation, so it does not contain information about acceptance criteria, device performance metrics, or study methodologies for an AI/software device.

Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance process for a physical medical device (surgical mesh) and confirms its substantial equivalence to a predicate device, not on the performance evaluation of a device through a clinical study.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.