Cleared Traditional

ZIMMER NEXEL TOTAL ELBOW

K123862 · Zimmer, Inc. · Orthopedic
Mar 2013
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K123862 is an FDA 510(k) clearance for the ZIMMER NEXEL TOTAL ELBOW, a Prosthesis, Elbow, Constrained, Cemented (Class II — Special Controls, product code JDC), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 12, 2013, 88 days after receiving the submission on December 14, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number K123862 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2012
Decision Date March 12, 2013
Days to Decision 88 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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