EcoFit® Hip System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Implantcast, GmbH

The following data is part of a premarket notification filed by Implantcast, Gmbh with the FDA for Ecofit® Hip System.

Pre-market Notification Details

• Device ID: K203420
• 510k Number: K203420
• Device Name: EcoFit® Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Implantcast, GmbH Luneburger Schanze 26 21614 Buxtehude, DE
• Contact: Juliane Hoppner
• Correspondent: Dave Mcgurl; MCRA, LLC. 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-19
• Decision Date: 2021-02-03