Cleared Traditional

Ventix Suture Anchor

K153558 · Biomet Manufacturing Corp · Orthopedic
Apr 2016
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K153558 is an FDA 510(k) clearance for the Ventix Suture Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on April 21, 2016, 129 days after receiving the submission on December 14, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K153558 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2015
Decision Date April 21, 2016
Days to Decision 129 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