Cleared Traditional

VERSA-DIAL HUMERAL HEAD

K040610 · Biomet Manufacturing, Inc. · Orthopedic

Jun 2004

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K040610 is an FDA 510(k) clearance for the VERSA-DIAL HUMERAL HEAD, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Biomet Manufacturing, Inc. (Warsaw,, US). The FDA issued a Cleared decision on June 4, 2004, 88 days after receiving the submission on March 8, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K040610 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2004
Decision Date	June 04, 2004
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660