Cleared Traditional

ToggleLoc System

K173278 · Biomet, Inc. · Orthopedic
Jan 2018
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K173278 is an FDA 510(k) clearance for the ToggleLoc System, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 5, 2018, 84 days after receiving the submission on October 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K173278 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2017
Decision Date January 05, 2018
Days to Decision 84 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