Cleared Special

K060696 - ACCLAIM TOTAL ELBOW SYSTEM
(FDA 510(k) Clearance)

K060696 · DePuy Orthopaedics, Inc. · Orthopedic

Apr 2006

Decision

29d

Days

Class 2

Risk

K060696 is an FDA 510(k) clearance for the ACCLAIM TOTAL ELBOW SYSTEM, a Prosthesis, Elbow, Constrained, Cemented (Class II — Special Controls, product code JDC), submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 14, 2006, 29 days after receiving the submission on March 16, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number	K060696 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2006
Decision Date	April 14, 2006
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF