Cleared Special

Exactech Alteon Monobloc Revision Stem

K181532 · Exactech, Inc. · Orthopedic

Sep 2018

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K181532 is an FDA 510(k) clearance for the Exactech Alteon Monobloc Revision Stem, 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 September 4, 2018, 85 days after receiving the submission on June 11, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K181532 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2018
Decision Date	September 04, 2018
Days to Decision	85 days
Submission Type	Special
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