Cleared Special

DISCOVERY ELBOW - X-SMALL

K090473 · Biomet Manufacturing Corp · Orthopedic
Mar 2009
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K090473 is an FDA 510(k) clearance for the DISCOVERY ELBOW - X-SMALL, 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 March 25, 2009, 29 days after receiving the submission on February 24, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3150.

Submission Details

510(k) Number K090473 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2009
Decision Date March 25, 2009
Days to Decision 29 days
Submission Type Special
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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