Cleared Traditional

LPS UPPER EXTREMITY

K042664 · Depuy, Inc. · Orthopedic
Dec 2004
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K042664 is an FDA 510(k) clearance for the LPS UPPER EXTREMITY, a Prosthesis, Elbow, Constrained, Cemented (Class II — Special Controls, product code JDC), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 8, 2004, 71 days after receiving the submission on September 28, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number K042664 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2004
Decision Date December 08, 2004
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDC — Prosthesis, Elbow, Constrained, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3150

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