Cleared Traditional

Exactech Alteon Modular Dual Mobility (MDM) System

K190890 · Exactech, Inc. · Orthopedic

Oct 2019

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K190890 is an FDA 510(k) clearance for the Exactech Alteon Modular Dual Mobility (MDM) System, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 22, 2019, 200 days after receiving the submission on April 5, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K190890 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2019
Decision Date	October 22, 2019
Days to Decision	200 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