Cleared Traditional

TunneLoc Tibial Fixation Device

K193092 · Biomet, Inc. · Orthopedic
Jan 2020
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K193092 is an FDA 510(k) clearance for the TunneLoc Tibial Fixation Device, 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 2, 2020, 57 days after receiving the submission on November 6, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K193092 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2019
Decision Date January 02, 2020
Days to Decision 57 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