Cleared Special

Biomet Headless Compression and Twist-Off Screws

K190035 · Biomet, Inc. · Orthopedic
Feb 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K190035 is an FDA 510(k) clearance for the Biomet Headless Compression and Twist-Off 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 7, 2019, 30 days after receiving the submission on January 8, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K190035 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2019
Decision Date February 07, 2019
Days to Decision 30 days
Submission Type Special
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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