Cleared Traditional

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow

K181307 · Zimmer, Inc. · Orthopedic
Jan 2019
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K181307 is an FDA 510(k) clearance for the Zimmer Nexel Total Elbow, Connrad/Morrey 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 January 28, 2019, 256 days after receiving the submission on May 17, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number K181307 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2018
Decision Date January 28, 2019
Days to Decision 256 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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