Cleared Traditional

EcoFit Vit E Acetabular System

K180263 · Implantcast GmbH · Orthopedic

Jul 2018

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K180263 is an FDA 510(k) clearance for the EcoFit Vit E Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on July 20, 2018, 171 days after receiving the submission on January 30, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K180263 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2018
Decision Date	July 20, 2018
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353