Cleared Traditional

Comprehensive SRS/Nexel Elbow

K153398 · Biomet Manufacturing Corp · Orthopedic
Feb 2016
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K153398 is an FDA 510(k) clearance for the Comprehensive SRS/Nexel Elbow, a Prosthesis, Elbow, Constrained, Cemented (Class II — Special Controls, product code JDC), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on February 3, 2016, 71 days after receiving the submission on November 24, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number K153398 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2015
Decision Date February 03, 2016
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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