FitRite™ Total Hip Arthroplasty System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

EXCERA ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Excera Orthopedics, Inc. with the FDA for Fitrite™ Total Hip Arthroplasty System.

Pre-market Notification Details

• Device ID: K153057
• 510k Number: K153057
• Device Name: FitRite™ Total Hip Arthroplasty System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: EXCERA ORTHOPEDICS, INC. 1188 Centre St Newton, MA 02459
• Contact: Scott Coleridge
• Correspondent: Kellen Hills; ORCHID DESIGN 4600 E SHELBY DR Memphis, TN 38118
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-21
• Decision Date: 2016-06-23
• Summary: summary