Cleared Traditional

Vantage Total Ankle Flat Cut Talar Components

K183343 · Exactech, Inc. · Orthopedic

Apr 2019

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K183343 is an FDA 510(k) clearance for the Vantage Total Ankle Flat Cut Talar Components, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on April 1, 2019, 119 days after receiving the submission on December 3, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K183343 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2018
Decision Date	April 01, 2019
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110