Cleared Traditional

TITANIUM TOGGLE BUTTON(S)

K033838 · Biomet Manufacturing, Inc. · Orthopedic
Feb 2004
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K033838 is an FDA 510(k) clearance for the TITANIUM TOGGLE BUTTON(S), a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 13, 2004, 65 days after receiving the submission on December 10, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K033838 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2003
Decision Date February 13, 2004
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040