Cleared Traditional

K083107 - MODIFICATION TO DEPUY NEUFLEX PIP FINGER
(FDA 510(k) Clearance)

K083107 · DePuy Orthopaedics, Inc. · Orthopedic

Feb 2009

Decision

112d

Days

Class 2

Risk

K083107 is an FDA 510(k) clearance for the MODIFICATION TO DEPUY NEUFLEX PIP FINGER, a Prosthesis, Finger, Constrained, Polymer (Class II — Special Controls, product code KYJ), submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 9, 2009, 112 days after receiving the submission on October 20, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3230.

Submission Details

510(k) Number	K083107 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2008
Decision Date	February 09, 2009
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF