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K Number
K110110
Device Name
ATRIUM CENTRILFX MESH
Manufacturer
ATRIUM MEDICAL CORPORATION
Date Cleared
2011-02-15

(32 days)

Product Code
FTL
Regulation Number
878.3300
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Atrium CentriFX Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Atrium CentriFX Mesh) and does not contain information related to the acceptance criteria or study details as one would find for an AI/ML medical device. This document is related to a surgical mesh, which is a physical implant, not a software algorithm.

Therefore, I cannot provide the requested information.

§ 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.