Cleared Traditional

Ventix Knotless Anchors

K152262 · Biomet Manufacturing Corp · Orthopedic
Mar 2016
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K152262 is an FDA 510(k) clearance for the Ventix Knotless Anchors, 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 March 8, 2016, 210 days after receiving the submission on August 11, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K152262 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2015
Decision Date March 08, 2016
Days to Decision 210 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