Cleared Traditional

TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS

K140390 · Biomet Manufacturing Corp · Orthopedic

Sep 2014

Decision

208d

Days

Class 2

Risk

About This 510(k) Submission

K140390 is an FDA 510(k) clearance for the TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 10, 2014, 208 days after receiving the submission on February 14, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K140390 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2014
Decision Date	September 10, 2014
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670