Cleared Special

Cadence Total Ankle System

K201507 · Integra LifeSciences Corporation · Orthopedic

Jun 2020

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K201507 is an FDA 510(k) clearance for the Cadence Total Ankle System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Integra LifeSciences Corporation (Austin, US). The FDA issued a Cleared decision on June 29, 2020, 24 days after receiving the submission on June 5, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K201507 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2020
Decision Date	June 29, 2020
Days to Decision	24 days
Submission Type	Special
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