Cleared Traditional

Exactech Alteon Highly Polished Femoral Stem

K182462 · Exactech, Inc. · Orthopedic

Nov 2018

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K182462 is an FDA 510(k) clearance for the Exactech Alteon Highly Polished Femoral 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 November 8, 2018, 59 days after receiving the submission on September 10, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K182462 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2018
Decision Date	November 08, 2018
Days to Decision	59 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