Cleared Traditional

Titanium Interference Screws

K193451 · Biomet, Inc. · Orthopedic
Feb 2020
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K193451 is an FDA 510(k) clearance for the Titanium Interference Screws, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 24, 2020, 73 days after receiving the submission on December 13, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K193451 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2019
Decision Date February 24, 2020
Days to Decision 73 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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