Cleared Traditional

INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM

K132250 · Integra LifeSciences Corporation · Orthopedic

Mar 2014

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K132250 is an FDA 510(k) clearance for the INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM, a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II — Special Controls, product code JWJ), submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on March 24, 2014, 248 days after receiving the submission on July 19, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K132250 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2013
Decision Date	March 24, 2014
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWJ — Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3800