FDA 510(k), K153057, FitRite Total Hip Arthroplasty System

510(K) Number: K153057
Device Name: FitRite Total Hip Arthroplasty System
Manufacturer: EXCERA ORTHOPEDICS, INC.
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Number: 888.3350
Classification Product Code: JDI
Date Received: 10/21/2015
Decision Date: 06/23/2016
Regulation Medical Specialty: Orthopedic