Cleared Traditional

WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws

K193214 · Biomet, Inc. · Orthopedic
Nov 2020
Decision
355d
Days
Class 2
Risk

About This 510(k) Submission

K193214 is an FDA 510(k) clearance for the WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws, 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 November 10, 2020, 355 days after receiving the submission on November 21, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K193214 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2019
Decision Date November 10, 2020
Days to Decision 355 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