Cleared Traditional

Exactech? Vantage? Total Ankle System

K230717 · Exactech, Inc. · Orthopedic

Oct 2023

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K230717 is an FDA 510(k) clearance for the Exactech? Vantage? Total Ankle System, 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 October 12, 2023, 211 days after receiving the submission on March 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K230717 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2023
Decision Date	October 12, 2023
Days to Decision	211 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