FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:

Device Description

Link Acetabular Mesh Cup and Sheet

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Acetabular Revision Mesh and Cup" (Link America, Inc. Acetabular Mesh Cup and Sheet). It confirms substantial equivalence and permits marketing of the device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document focusing on substantial equivalence to previously marketed devices. Therefore, I cannot extract the requested details from the given input.

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K Number

K964458

Device Name

ELLIS EXTERNAL MINI-FIXATOR SYSTEM

Manufacturer

LINK AMERICA, INC.

Date Cleared

1996-12-09

(32 days)

Product Code