FDA 510(k), K181557, INFINITY Total Ankle System

510(K) Number: K181557
Device Name: INFINITY Total Ankle System
Manufacturer: Wright Medical Technology, Inc.
Device Classification Name: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation Number: 888.3110
Classification Product Code: HSN
Date Received: 06/13/2018
Decision Date: 08/09/2018
Regulation Medical Specialty: Orthopedic

198 pages (638 of 826 original pages are fully redacted)