Cleared Traditional

ALLthread Titanium Suture Anchor

K192942 · Biomet, Inc. · Orthopedic
Jan 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K192942 is an FDA 510(k) clearance for the ALLthread Titanium Suture Anchor, 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 16, 2020, 90 days after receiving the submission on October 18, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K192942 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2019
Decision Date January 16, 2020
Days to Decision 90 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